Targeting 2.5 versus 4 g/kg/day of amino acids for extremely low birth weight infants: a randomized clinical trial.

PubMed

Burattini, Ilaria; Bellagamba, Maria Paola; Spagnoli, Cristina; D'Ascenzo, Rita; Mazzoni, Nadia; Peretti, Anna; Cogo, Paola E; Carnielli, Virgilio P

2013-11-01

To compare the effect of 2.5 vs 4 g/kg/d of amino acid (AA) in parenteral nutrition of extremely low birth weight infants on metabolic tolerance, short-term growth, and neurodevelopment. One hundred thirty-one infants with birth weight between 500 and 1249 g were randomized to 2.5 (standard AA [SAA] group) or 4 (high AA [HAA] group) g/kg/d AA intake, with equal nonprotein energy. The primary outcome was body size at 36 weeks. One hundred thirty-one patients were randomized and 114 analyzed (58 SAA group and 56 HAA group). Study groups had similar demographics and clinical characteristics. Elevated blood urea (BU >70 mg/dL = BU nitrogen >32.6 mg/dL) occurred in 24% vs 59% (P = .000) and hyperglycemia (>175 mg/dL) in 34% vs 11% (P = .003) of the SAA and HAA patients, respectively. Body weight, length, and head circumference at 36 weeks and 2 years were similar between groups. Bayley Scales of Infant and Toddler Development, Third Edition score was 94 ± 13 in the SAA group and 97 ± 15 in the HAA group (P = .35). The HAA group had higher BU levels and better glucose control. An extra 8 g/kg of AA over the first 10 days of life did not improve growth and neurodevelopment. Copyright © 2013 Mosby, Inc. All rights reserved.

Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial.

PubMed

Knip, Mikael; Åkerblom, Hans K; Al Taji, Eva; Becker, Dorothy; Bruining, Jan; Castano, Luis; Danne, Thomas; de Beaufort, Carine; Dosch, Hans-Michael; Dupre, John; Fraser, William D; Howard, Neville; Ilonen, Jorma; Konrad, Daniel; Kordonouri, Olga; Krischer, Jeffrey P; Lawson, Margaret L; Ludvigsson, Johnny; Madacsy, Laszlo; Mahon, Jeffrey L; Ormisson, Anne; Palmer, Jerry P; Pozzilli, Paolo; Savilahti, Erkki; Serrano-Rios, Manuel; Songini, Marco; Taback, Shayne; Vaarala, Outi; White, Neil H; Virtanen, Suvi M; Wasikowa, Renata

2018-01-02

Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. The participants received either a casein hydrolysate or a conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8% [95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2

Review of Randomized Controlled Trials of Massage in Preterm Infants

PubMed Central

Niemi, Anna-Kaisa

2017-01-01

Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants. PMID:28368368

A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants: A Randomized Clinical Trial

PubMed Central

Munoz, Flor M.; Bond, Nanette H.; Maccato, Maurizio; Pinell, Phillip; Hammill, Hunter A.; Swamy, Geeta K.; Walter, Emmanuel B.; Jackson, Lisa A.; Englund, Janet A.; Edwards, Morven S.; Healy, C. Mary; Petrie, Carey R.; Ferreira, Jennifer; Goll, Johannes B.; Baker, Carol J.

2015-01-01

Importance Maternal immunization with tetanus toxoid and reduced diphtheria toxoid acellular pertussis (Tdap) vaccine could prevent infant pertussis. The effect of vaccine-induced maternal antibodies on infant responses to diphtheria and tetanus toxoids acellular pertussis (DTaP) immunization is unknown. Objective To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to DTaP. Design, Setting and Participants Phase I, randomized, double-masked, placebo-controlled clinical trial conducted in private (Houston) and academic (Durham, Seattle) obstetric practices from 2008 to 2012. Forty eight healthy 18–45 year-old pregnant women received Tdap (n=33) or placebo (n=15) at 30–32 weeks’ gestation with cross-over Tdap immunization postpartum. Interventions Tdap vaccination at 30–32 weeks’ gestation or post-partum. Outcome Measures Primary: Maternal and infant adverse events, pertussis illness and infant growth and development (Bayley-III screening test) until 13 months of age. Secondary: Antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months postpartum, and in infants at birth, 2 months, and after the third (7 months) and fourth (13 months) doses of DTaP. Results All participants delivered healthy newborns. No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 78.8% (95% CI: 61.1%, 91.0%) and 80% (CI: 51.9%, 95.7%) pregnant and postpartum women, respectively. Injection site pain was the predominant symptom. Systemic symptoms were reported in 36.4% (CI: 20.4%, 54.9%) and 73.3% (CI: 44.9%, 92.2%) pregnant and postpartum women, respectively. Malaise and myalgia were most common. Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in

Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

2008-01-01

This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

Infant botulism: review and clinical update.

PubMed

Rosow, Laura K; Strober, Jonathan B

2015-05-01

Botulism is a rare neuromuscular condition, and multiple clinical forms are recognized. Infant botulism was first identified in the 1970s, and it typically occurs in infants younger than 1 year of age who ingest Clostridium botulinum spores. A specific treatment for infant botulism, intravenous botulism immunoglobulin (BIG-IV or BabyBIG®), was developed in 2003, and this treatment has substantially decreased both morbidity and hospital costs associated with this illness. This article will review the pathogenesis of infant botulism as well as the epidemiology, clinical manifestations, diagnosis, and treatment of this condition. Copyright © 2015 Elsevier Inc. All rights reserved.

Changes in energy expenditure in preterm infants during weaning: a randomized comparison of two weaning methods from an incubator.

PubMed

Weintraub, Valentin; Mimouni, Francis B; Dollberg, Shaul

2007-03-01

We aimed to compare resting energy expenditure (REE) of infants exposed to either one of two weaning methods and to confirm the increase in REE during weaning from incubator. The study was a prospective randomized clinical trial of weaning preterm infants using either of two methods. REE was measured at baseline and 6, 23, 30, and 47 h, using indirect calorimetry. At measurement, infants were clinically and thermally stable, asleep, 2 h after feeding. Forty-two patients were randomized to "open incubator" (n = 23) or "warming bassinet" (n = 19). The groups did not differ in baseline clinical characteristics. REE increased significantly in both groups within 23 h, and remained stable at 30 and 47 h. At 6 and 23 h, the incubator group had significantly higher increase in REE than the warming bassinet group. By 30 h and at 47 h post-weaning, the REE of both groups became similar. In conclusion, REE increases significantly at weaning from incubator. The warming bassinet delays the increase in REE observed when infants are weaned using a turned off incubator. Whether one method is superior to the other in terms of thermic stress cannot be determined from this study.

Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial.

PubMed

Amini, E; Rafiei, P; Zarei, K; Gohari, M; Hamidi, M

2013-01-01

Music is considered a subset of developmental supportive care. It may act as a suitable auditory stimulant in preterm infants. Also, it may reduce stress responses in autonomic, motor and state systems. To assess and compare the influence of lullaby and classical music on physiologic parameters. This is a randomized clinical trial with cross-over design. A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days. Each infant was exposed to three phases: lullaby music, classical music, and no music (control) for two days each. The sequence of these phases was assigned randomly to each subject. Babies were continuously monitored for heart rate, respiratory rate, and oxygen saturation and changes between phases were analyzed. Lullaby reduced heart rate (p < 0.001) and respiratory rate (p = 0.004). These effects extended in the period after the exposure (p < .001 and p = 0.001, respectively). Classical music reduced heart rate (p = 0.018). The effects of classical music disappeared once the music stopped. Oxygen saturation did not change during intervention. Music can affect vital signs of preterm infants; this effect can possibly be related to the reduction of stress during hospitalization. The implications of these findings on clinical and developmental outcomes need further study.

Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial.

PubMed

Pickler, Rita H; Wetzel, Paul A; Meinzen-Derr, Jareen; Tubbs-Cooley, Heather L; Moore, Margo

2015-06-04

Neurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes. This trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors

Effects of mother-infant skin-to-skin contact on severe latch-on problems in older infants: a randomized trial.

PubMed

Svensson, Kristin E; Velandia, Marianne I; Matthiesen, Ann-Sofi T; Welles-Nyström, Barbara L; Widström, Ann-Marie E

2013-03-11

Infants with latch-on problems cause stress for parents and staff, often resulting in early termination of breastfeeding. Healthy newborns experiencing skin-to-skin contact at birth are pre-programmed to find the mother's breast. This study investigates if skin-to-skin contact between mothers with older infants having severe latching on problems would resolve the problem. Mother-infant pairs with severe latch-on problems, that were not resolved during screening procedures at two maternity hospitals in Stockholm 1998-2004, were randomly assigned to skin-to-skin contact (experimental group) or not (control group) during breastfeeding. Breastfeeding counseling was given to both groups according to a standard model. Participants were unaware of their treatment group. Objectives were to compare treatment groups concerning the proportion of infants regularly latching on, the time from intervention to regular latching on and maternal emotions and pain before and during breastfeeding. On hundred and three mother-infant pairs with severe latch-on problems 1-16 weeks postpartum were randomly assigned and analyzed. There was no significant difference between the groups in the proportion of infants starting regular latching-on (75% experimental group, vs. 86% control group). Experimental group infants, who latched on, had a significantly shorter median time from start of intervention to regular latching on than control infants, 2.0 weeks (Q1 = 1.0, Q3 = 3.7) vs. 4.7 weeks (Q1 = 2.0, Q3 = 8.0), (p-value = 0.020). However, more infants in the experimental group (94%), with a history of "strong reaction" during "hands-on latch intervention", latched-on within 3 weeks compared to 33% in the control infants (Fisher Exact test p-value = 0.0001). Mothers in the experimental group (n = 53) had a more positive breastfeeding experience according to the Breastfeeding Emotional Scale during the intervention than mothers in the control group (n = 50) (p-value = 0.022). Skin-to-skin contact

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial.

PubMed

Wadhwa, Nitya; Basnet, Sudha; Natchu, Uma Chandra Mouli; Shrestha, Laxman P; Bhatnagar, Shinjini; Sommerfelt, Halvor; Strand, Tor A; Ramji, Siddarth; Aggarwal, K C; Chellani, Harish; Govil, Anuradha; Jajoo, Mamta; Mathur, N B; Bhatt, Meenakshi; Mohta, Anup; Ansari, Imran; Basnet, Srijana; Chapagain, Ram H; Shah, Ganesh P; Shrestha, Binod M

2017-07-10

An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.

Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial.

PubMed

Maas, Christoph; Mathes, Michaela; Bleeker, Christine; Vek, Julia; Bernhard, Wolfgang; Wiechers, Cornelia; Peter, Andreas; Poets, Christian F; Franz, Axel R

2017-01-01

Protein, supplied in currently available commercial fortifiers, may be inadequate to meet the requirements of very preterm infants; in addition, intraindividual and interindividual variability of human milk protein and energy content potentially contribute to unsatisfactory early postnatal growth. To determine effects on growth of different levels of enteral protein supplementation in predominantly human milk-fed preterm infants. This randomized clinical and partially blinded single-center trial was conducted in a neonatal tertiary referral center in Germany. Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth) were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (interquartile range [IQR]) gestational age at birth was 29.9 (28.7-31.2) weeks. All analyses were conducted in an intention-to-treat population. Infants were randomly assigned to either a lower-protein (adding 1 g of bovine protein/100 mL of breast milk through a commercial human milk fortifier; n = 30) or a higher-protein group at a median (IQR) postnatal age of 7 (6-8) days. The higher-protein group (n = 30) received either standardized higher-protein supplementation (study fortifier adding 1.8 g of bovine protein/100 mL of breast milk [n = 15]) or individualized high-protein supplementation based on protein and fat content of administered breast milk (n = 15). Study interventions were continued for a median (IQR) of 41 (30-57) days and until definite discharge planning. Primary outcome was weight gain (g/kg/d) from birth to the end of intervention. Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth), 33 girls, were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (IQR) gestational age at birth was 29.9 (28.7-31.2) weeks. Demographic characteristics and hospital courses were similar in both groups, and birth weights ranged from 580 to 1495 g in the lower

Comparison of the Effect of Plastic Cover and Blanket on Body Temperature of Preterm Infants Hospitalized in NICU: Randomized Clinical Trial

PubMed Central

Valizadeh, Leila; Mahallei, Majid; Safaiyan, Abdolrasoul; Ghorbani, Fatemeh; Peyghami, Maryam

2017-01-01

Introduction: Preterm infants are unable to regulate their body temperature and there are insufficient research evidences on different kinds of covers for hospitalized preterm infants; therefore, the present study was conducted with the aim of comparing the effects of plastic and blanket covers on the body temperature of preterm infants under radiant warmer. Methods: This randomized cross-over clinical trial was carried out upon 80 infants with the gestational age of 28-30 weeks and birth weight of 800- 1250 gr who were in Neonatal Intensive Care Unit on the second day of their hospitalization. The study lasted for two days. In group 1, the plastic cover was used during the first day of the study while the blankets were used during the second day. Infants’ heads were kept out of the cover and coated with a hat. In group 2, the plastic cover was used during the first day of the study while the blanket was used during second day. Digital thermometer was used to measure infants’ axillary temperature. The data was analyzed using SPSS ver 13 and MiniTab software. Descriptive statistics, (Mean (SE), 95%CI) and inferential statistics (Repeated measurement and ANCOVA tests) were used. Results: The mean body temperature of the infants in the group covered with the plastic was calculated to be higher and the warmer was set on low temperature. Conclusion: Using plastic cover during the first few days of hospitalization in NICU resulted in regulation of preterm infants’ body temperature. PMID:28680870

Prebiotic effect of an infant formula supplemented with galacto-oligosaccharides: randomized multicenter trial.

PubMed

Giovannini, Marcello; Verduci, Elvira; Gregori, Dario; Ballali, Simonetta; Soldi, Sara; Ghisleni, Diana; Riva, Enrica

2014-01-01

The objective of the study was to investigate the effects of a galacto-oligosaccharides (GOS)-supplemented formula on the intestinal microbiota in healthy term infants, with a specific consideration for gastrointestinal symptoms as colic, stool frequency and consistency, regurgitation. This was a randomized, double-blind, controlled, parallel-group clinical trial performed simultaneously by 6 centers in Italy. Three groups were considered: breastfed, formula-fed, and GOS-supplemented formula-fed infants. Formula-fed infants were randomized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding. The nutritional composition of the 2 formulas were identical, apart from the supplemented GOS (0.4 g/100 mL) in the study formula. Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants: Bifidobacterium, Lactobacillus, and Clostridium, Escherichia coli. A total of 199 breastfed infants and 163 formula-fed infants were recruited. When considering stool frequency and consistency, GOS-supplemented formula presented normal and soft stools in the majority of episodes (89%). In the supplemented group the incidence of colic was lower with respect to the control group. A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic. In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one. The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth, resulting in a significantly lower presence of colic.

Early Caffeine and Weaning from Mechanical Ventilation in Preterm Infants: A Randomized, Placebo-Controlled Trial.

PubMed

Amaro, Cynthia M; Bello, Jose A; Jain, Deepak; Ramnath, Alexandra; D'Ugard, Carmen; Vanbuskirk, Silvia; Bancalari, Eduardo; Claure, Nelson

2018-05-01

To evaluate in a randomized, double-blind, placebo-controlled trial the effect of early caffeine on the age of first successful extubation in preterm infants. Preterm infants born at 23-30 weeks of gestation requiring mechanical ventilation in the first 5 postnatal days were randomized to receive a 20 mg/kg loading dose followed by 5 mg/kg/day of caffeine or placebo until considered ready for extubation. The placebo group received a blinded loading dose of caffeine before extubation. Infants were randomized to receive caffeine (n = 41) or placebo (n = 42). Age at first successful extubation did not differ between early caffeine (median, 24 days; IQR, 10-41 days) and control groups (median, 20 days; IQR, 9-43 days; P = .7). An interim analysis at 75% enrollment showed a trend toward higher mortality in 1 of the groups and the data safety and monitoring board recommended stopping the trial. Unblinded analysis revealed mortality did not differ significantly between the early caffeine (9 [22%]) and control groups (5 [12%]; P = .22). Early initiation of caffeine in this group of premature infants did not reduce the age of first successful extubation. A nonsignificant trend toward higher mortality in the early caffeine group led to a cautious decision to stop the trial. These findings suggest caution with early use of caffeine in mechanically ventilated preterm infants until more efficacy and safety data become available. ClinicalTrials.gov: NCT01751724. Copyright © 2018 Elsevier Inc. All rights reserved.

Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants.

PubMed

Giannì, Maria Lorella; Roggero, Paola; Amato, Orsola; Picciolini, Odoardo; Piemontese, Pasqua; Liotto, Nadia; Taroni, Francesca; Mosca, Fabio

2014-03-19

Preterm infants are at risk for adverse neurodevelopment. Furthermore, nutrition may play a key role in supporting neurodevelopment. The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months (term-corrected age). We conducted an observer-blinded, single-center, randomized controlled trial in infants admitted to the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy between 2009 and 2011. Inclusion criteria were gestational age < 32 weeks and/or birth weight < 1500 g, and being fed human milk for < 20% of the total milk intake. Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition. Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until 6 months of corrected age, using two computer-generated randomization lists; one appropriate for gestational age (AGA) and one for small for gestational age (SGA) infants. We assessed neurodevelopment at 24 months of corrected age using the Griffiths Mental Development Scale and related subscales (locomotor, personal-social, hearing and speech, hand and eye coordination, and performance). Of the 207 randomized infants, 181 completed the study. 52 AGA and 35 SGA infants were fed a nutrient-enriched formula, whereas 56 AGA and 38 SGA infants were fed a standard full-term formula. The general quotient at 24 months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until 6 months of corrected age (AGA infants: 93.8 ± 12.6 vs. 92.4 ± 10.4, respectively; SGA infants: 96.1 ± 9.9 vs. 98.2 ± 9, respectively). The scores of related subscales were also similar among groups. This study found that feeding preterm infants a nutrient-enriched formula after discharge does not

Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo.

PubMed

Ohls, Robin K; Kamath-Rayne, Beena D; Christensen, Robert D; Wiedmeier, Susan E; Rosenberg, Adam; Fuller, Janell; Lacy, Conra Backstrom; Roohi, Mahshid; Lambert, Diane K; Burnett, Jill J; Pruckler, Barbara; Peceny, Hannah; Cannon, Daniel C; Lowe, Jean R

2014-06-01

We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin (Darbe) or erythropoietin (Epo) compared with placebo. As these erythropoiesis-stimulating agents (ESAs) have shown promise as neuroprotective agents, we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs. We performed a randomized, masked, multicenter study comparing Darbe (10 μg/kg, 1×/week subcutaneously), Epo (400 U/kg, 3×/week subcutaneously), and placebo (sham dosing 3×/week) given through 35 weeks' postconceptual age, with transfusions administered according to a standardized protocol. Surviving infants were evaluated at 18 to 22 months' corrected age using the Bayley Scales of Infant Development III. The primary outcome was composite cognitive score. Assessments of object permanence, anthropometrics, cerebral palsy, vision, and hearing were performed. Of the original 102 infants (946 ± 196 g, 27.7 ± 1.8 weeks' gestation), 80 (29 Epo, 27 Darbe, 24 placebo) returned for follow-up. The 3 groups were comparable for age at testing, birth weight, and gestational age. After adjustment for gender, analysis of covariance revealed significantly higher cognitive scores among Darbe (96.2 ± 7.3; mean ± SD) and Epo recipients (97.9 ± 14.3) compared with placebo recipients (88.7 ± 13.5; P = .01 vs ESA recipients) as was object permanence (P = .05). No ESA recipients had cerebral palsy, compared with 5 in the placebo group (P < .001). No differences among groups were found in visual or hearing impairment. Infants randomized to receive ESAs had better cognitive outcomes, compared with placebo recipients, at 18 to 22 months. Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants. Copyright © 2014 by the American Academy of Pediatrics.

Effect of probiotics on digestibility and immunity in infants: A study protocol for a randomized controlled trial.

PubMed

Xiao, Lingli; Ding, Guodong; Ding, Yifang; Deng, Chaoming; Ze, Xiaolei; Chen, Liang; Zhang, Yao; Song, Lihua; Yan, Hongli; Liu, Fang; Ben, Xiaoming

2017-04-01

The gastrointestinal (GI) tract of a fetus in utero is sterile but it becomes colonized with environmental microorganisms shortly after birth. Since the gut microbiota undergoes substantial changes in early life, healthy gut microflora is essential to an infant's gut health and immune system and probably also has an effect on overall health status in later life. Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although randomized controlled trials using probiotics in infants have shown promising results in the prevention and treatment of common diseases such as diarrhea and allergy, little is known about whether probiotics could offer benefits to healthy infants. We have designed a randomized controlled trial to test the hypothesis that an oral preparation of probiotics is superior to placebo in improving digestive and immune function in healthy infants.The trial will be a randomized, double-blind, placebo-controlled, 2-parallel-group study in Shanghai, China. After a 2-week run-in period, 200 exclusively formula-fed healthy infants aged 4 to 6 months will be randomly allocated to receive either a probiotic product containing Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052 or an identical placebo once daily for 4 weeks and will be followed up for 8 weeks. The duration of the subject's participation will be 14 weeks, with a total of 5 visits: inclusion (Visit 1, Day 1), start of intervention (V2, D15), end of intervention (V3, D44), and follow-up (V4 and V5, D72 and D100). Stool and saliva samples will be collected at the first 3 visits to measure microbial populations and secretory immunoglobulin A (SIgA), respectively. Physical examination will be performed at each visit, and tolerance records will be completed 1 day prior to each visit. The primary endpoints will be the changes in the composition of fecal microbiota

Intervention for infants with brain injury: Results of a randomized controlled study

PubMed Central

Badr, Lina Kurdahi; Garg, Meena; Kamath, Meghna

2009-01-01

A randomized clinical trail (RCT) employed a 12-month individualized cognitive/sensorimotor stimulation program to look at the efficacy of the intervention on 62 infants with suspected brain injury. The control group infants received the State-funded follow-up program provided by the Los Angeles (LA) Regional Centers while the intervention group received intensive stimulation using the Curriculum and Monitoring System (CAMS) taught by public health nurses (PHNs). The developmental assessments and outcome measures were performed at 6, 12 and 18 months corrected age and included the Bayley motor and mental development, the Home, mother–infant interaction (Nursing Child Assessment Feeding Scale (NCAFS) and Nursing Child Assessment Teaching Scale (NCATS)), parental stress and social support. At 18 months, 43 infants remained in the study. The results indicate that the intervention had minimal positive effects on the Bayley mental and motor development scores of infants in the intervention group. Likewise, the intervention did not contribute to less stress or better mother–infant interaction at 12 or 18 months although there were significant differences in the NCAFS scores favoring the intervention group at 6 months. There was a significant trend, however, for the control group to have a significant decrease over time on the Bayley mental scores. Although the sample was not large and attrition was at 31%, this study provides further support to the minimal effects of stimulation and home intervention for infants with brain injury and who may have more significant factors contributing to their developmental outcome. PMID:17138264

Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial.

PubMed

Bache, Manon; Pizon, Emmanuelle; Jacobs, Julien; Vaillant, Michel; Lecomte, Aline

2014-03-01

To evaluate the effect of early oral stimulation before the introduction of oral feeding, over the duration of concomitant tube feeding ("transition period"), the length of hospital stay and the breastfeeding rates upon discharge in preterm infants. Preterm infants born between 26 and 33 weeks gestational age (n=86), were randomized into an intervention and control group. Infants in the intervention group received an oral stimulation program consisting in stimulation of the oral structures for 15 min at least for 10 days, before introduction of oral feeding. Oral feeding was introduced at 34 weeks GA in both groups. Breastfeeding rates upon discharge were significantly higher in the intervention than in the control group (70% versus 45.6%, p=0.02). There was no statistical difference between the two groups in terms of the length of the transition period or the length of the hospital stay. The need for prolonged CPAP support (HR=0.937, p=0.030) and small size for gestational age at birth (HR=0.338, p=0.016) were shown to be risk factors for a prolonged transition period. A pre-feeding oral stimulation program improves breastfeeding rates in preterm infants. The study results suggest that oral stimulation, as used in our specific population, does not shorten the transition period to full oral feeding neither the length of hospital stay. Copyright © 2014 Elsevier Ltd. All rights reserved.

Cluster-randomized trial of infant nutrition training for caries prevention.

PubMed

Chaffee, B W; Feldens, C A; Vítolo, M R

2013-07-01

The objective of this study was to estimate the caries impact of providing training in infant feeding guidelines to workers at Brazilian public primary care clinics. In a cluster-randomized controlled trial (n = 20 clinics), health care workers either were trained in guidelines for infant nutrition, stressing healthful complementary feeding, or were assigned to a 'usual practices' control, which allowed for maternal counseling at practitioner discretion. Training occurred once; the amount of counseling provided to mothers was not assessed. Eligible pregnant women were enrolled to follow health outcomes in their children. Early childhood caries (ECC) was measured at age three years (n = 458 children). The overall reductions in ECC (relative risk, 0.92; 95%CI, 0.75, 1.12) and severe ECC (RR, 0.87; 95%CI, 0.64, 1.19) were not statistically significant. There was a protective effect among mothers who remained exclusively at the same health center (S-ECC RR, 0.68; 95%CI, 0.47, 0.99) and among those naming the health center as their principal source of feeding advice (S-ECC RR, 0.53; 95%CI, 0.29, 0.97). Health care worker training did not yield a statistically significant reduction in caries overall, although caries was reduced among children of mothers more connected to their health centers.

Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial.

PubMed

Stephenson, Kevin B; Agapova, Sophia E; Divala, Oscar; Kaimila, Yankho; Maleta, Kenneth M; Thakwalakwa, Chrissie; Ordiz, M Isabel; Trehan, Indi; Manary, Mark J

2017-12-01

Background: Growth faltering is common in rural African children and is attributed to inadequate dietary intake and environmental enteric dysfunction (EED). Objective: We tested the hypothesis that complementary feeding with cowpea or common bean flour would reduce growth faltering and EED in 6-mo-old rural Malawians compared with the control group receiving a corn-soy blend. Design: A prospective, double-blind, randomized controlled clinical trial was conducted in which children received daily feeding for 6 mo (200 kcal/d when 6-9 mo old and 300 kcal/d when 10-12 mo old). The primary outcomes were change in length-for-age z score (LAZ) and improvements in EED, as measured by percentage of lactulose excretion (%L). %L <0.2% was considered normal. Anthropometric measurements and %L through urine were compared between each legume group and the control group with Student's t test. Results: Of the 355 infants enrolled, 291 infants completed the trial, and 288 were breastfed throughout the duration of the study. Cowpea and common bean added 4.6-5.2 g protein/d and 4-5 g indigestible carbohydrate/d to the diet. LAZ and weight-for-height z score were reduced in all 3 groups from 6 to 12 mo of age. The changes in LAZ [mean (95% CI)] for the cowpea, common bean, and control groups from 6 to 9 mo were -0.14 (-0.24, -0.04), -0.27 (-0.38, -0.16), and -0.27 (-0.35, -0.19), respectively. LAZ was reduced less in infants receiving cowpea than in those receiving control food from 6 to 9 mo ( P = 0.048). The absolute value of %L did not differ between the dietary groups at 9 mo of age (mean ± SD: 0.30 ± 0.43, 0.23 ± 0.21, and 0.26 ± 0.31 for cowpea, common bean, and control, respectively), nor did the change in %L from 6 to 9 mo. Conclusion: Addition of cowpea to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT02472262. © 2017 American Society for Nutrition.

Infant botulism: clinical spectrum and epidemiology.

PubMed

Thompson, J A; Glasgow, L A; Warpinski, J R; Olson, C

1980-12-01

Between 1977 and 1979, 12 cases of infant botulism were diagnosed in Utah, and 87 control patients (normal, nonbotulism neurologic disease, and nonbotulism systemic disease) were evaluated. Observations from these patients suggest an expanded clinical spectrum of infant botulism including asymptomatic carriers of organism; mild hypotonia and failure to thrive; typical cases with constipation, bulbar weakness, and hypotonia; and children with a picture compatible with sudden infant death syndrome. Clostridium botulinum was isolated from the stools of three normal control infants and nine control infants who had neurologic diseases that were clearly not infant botulism. These infants were termed "asymptomatic carriers" of the organism. The occurrence of the asymptomatic carrier state suggests that a diagnosis of infant botulism cannot be made on a basis of culture results alone, but must rest in historical documentation and physical confirmation of progressive bulbar and extremity weakness with ultimate complete resolution of symptoms and findings over a period of several months. A common set of environmental features characterizes the home environment of children with infant botulism and "asymptomatic carriers" and includes: nearby constructional or agricultural soil disruption, dusty and windy conditions, a high water table, and alkaline soil conditions.

Growth of healthy term infants fed partially hydrolyzed whey-based infant formula: a randomized, blinded, controlled trial.

PubMed

Borschel, Marlene W; Choe, Yong S; Kajzer, Janice A

2014-12-01

Partially hydrolyzed formulas (pHF) represent a significant percentage of the infant formula market. A new whey-based, palm olein oil (PO)-free pHF was developed and a masked, randomized, parallel growth study was conducted in infants fed this formula or a commercially available whey-based pHF with PO. Infants between 0 and 8 days were to be enrolled and studied to 119 days of age. Growth and tolerance of infants were evaluated. Mean weight gain from 14 to 119 days of age was similar between groups. There were no significant differences between groups in weight, length, head circumference (HC), or length or HC gains. Infants fed the new PO-free pHF had significantly softer stools than those fed the PO-containing formula except at 119 days of age. This study demonstrates that whereas growth of infants fed different formulas during the first 4 months of life may be similar, infants may tolerate individual formulas differently. © The Author(s) 2014.

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

PubMed

Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

2014-01-30

Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

PubMed Central

2014-01-01

Background Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. Methods/Design This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. Discussion The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

Risk Factors for Early and Late Transmission of HIV via Breast-Feeding among Infants Born to HIV-Infected Women in a Randomized Clinical Trial in Botswana

PubMed Central

Shapiro, Roger L.; Smeaton, Laura; Lockman, Shahin; Thior, lbou; Rossenkhan, Raabya; Wester, Carolyn; Stevens, Lisa; Moffat, Claire; Arimi, Peter; Ndase, Patrick; Asmelash, Aida; Leidner, Jean; Novitsky, Vladimir; Makhema, Joseph; Essex, Max

2009-01-01

Risk factors for mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) via breast-feeding were evaluated in a randomized trial. HIV-infected women and their infants received zidovudine as well as single-dose nevirapine or placebo. Infants were randomized to formula-feed (FF) or breast-feed (BF) in combination with zidovudine prophylaxis. Of 1116 at-risk infants, 6 (1.1%) in the FF group and 7 (1.3%) in the BF group were infected between birth and 1 month)P = .99). Maternal receipt of nevirapine did not predict early MTCT in the BF group (P = .45). Of 547 infants in the BF group at risk for late MTCT, 24 (4.4%) were infected. Maternal HIV-1 RNA levels in plasma (P<.001) and breast milk (P<.001) predicted late MTCT. These findings support the safety of 1 month of breast-feeding in combination with maternal and infant antiretroviral prophylaxis. PMID:19090775

Family-based obesity prevention for infants: Design of the "Mothers & Others" randomized trial.

PubMed

Wasser, Heather M; Thompson, Amanda L; Suchindran, Chirayath M; Hodges, Eric A; Goldman, Barbara D; Perrin, Eliana M; Faith, Myles S; Bulik, Cynthia M; Heinig, M Jane; Bentley, Margaret E

2017-09-01

Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina. Mothers and study partners in the intervention group receive anticipatory guidance on breastfeeding, responsive feeding, use of non-food soothing techniques for infant crying, appropriate timing and quality of complementary feeding, age-appropriate infant sleep, and minimization of TV/media. The primary delivery channel is 6 home visits by a peer educator, 4 interim newsletters and twice-weekly text messaging. Intervention families also receive 2 home visits from an International Board Certified Lactation Consultant. Assessments occur at 28 and 37weeks gestation and when infants are 1, 3, 6, 9, 12, and 15months of age. The primary outcome is infant/toddler growth and likelihood of overweight at 15months. Differences between groups are expected to be achieved through uptake of the targeted infant feeding and care behaviors (secondary outcomes) and change in caregivers' modifiable risk factors (mediators) underpinning the intervention. If successful in promoting healthy infant growth and enhancing caregiver behaviors, "Mothers and Others" will have high public health relevance for future obesity-prevention efforts aimed at children younger than 2years, including interventional research and federal, state, and community health programs. ClinicalTrials.gov, NCT01938118, August 9, 2013. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants: The Early Nutrition Study Randomized Clinical Trial.

PubMed

Corpeleijn, Willemijn E; de Waard, Marita; Christmann, Viola; van Goudoever, Johannes B; Jansen-van der Weide, Marijke C; Kooi, Elisabeth M W; Koper, Jan F; Kouwenhoven, Stefanie M P; Lafeber, Hendrik N; Mank, Elise; van Toledo, Letty; Vermeulen, Marijn J; van Vliet, Ineke; van Zoeren-Grobben, Diny

2016-07-01

Infections and necrotizing enterocolitis, major causes of mortality and morbidity in preterm infants, are reduced in infants fed their own mother's milk when compared with formula. When own mother's milk is not available, human donor milk is considered a good alternative, albeit an expensive one. However, most infants at modern neonatal intensive care units are predominantly fed with own mother's milk. The benefits of add-on donor milk over formula are not clear. To determine whether providing donor milk instead of formula as supplemental feeding whenever own mother's milk is insufficiently available during the first 10 days of life reduces the incidence of serious infection, necrotizing enterocolitis, and mortality. The Early Nutrition Study was a multicenter, double-blind randomized clinical trial in very low-birth-weight infants (birth weight <1500 g) admitted to 1 of 6 neonatal intensive care units in the Netherlands from March 30, 2012, through August 17, 2014. Intent-to-treat analysis was performed. Infants received pasteurized donor milk or preterm formula during the first 10 days of life if own mother's milk was not (sufficiently) available. The primary end point was cumulative occurrence of serious infection (sepsis or meningitis), necrotizing enterocolitis, or mortality during the first 60 days of life. A total of 930 infants were screened for inclusion; 557 were excluded, resulting in 373 infants (183 receiving donor milk and 190 receiving formula) who were evaluated by intent-to-treat analysis (median birth weight, 1066 g; mean gestational age, 28.4 weeks). Own mother's milk comprised 89.1% and 84.5% of total mean intake during the intervention period for the donor milk and formula groups, respectively. The incidence of the combined outcome was not different (85 [44.7%] [formula] vs 77 [42.1%] [donor milk]; mean difference, 2.6%; 95% CI, -12.7% to 7.4%). The adjusted hazard ratio was 0.87 (95% CI, 0.63-1.19; P = .37). In the current study

Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial

PubMed Central

2013-01-01

Background The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvements in several clinical outcomes. The aim of the present study is to investigate the effect of OMT on LOS in premature infants. Methods A randomized controlled trial was conducted on preterm newborns admitted to a single NICU between 2008-2009. N=110 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized in two groups: study group (N=55) and control group (N=55). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain. Results Results showed a significant association between OMT and LOS reduction (mean difference between treated and control group: -5.906; 95% C.I. -7.944, -3.869; p<0.001). OMT was not associated to any change in daily weight gain. Conclusions The present study suggests that OMT may have an important role in the management of preterm infants hospitalization. Trial registration ClinicalTrials.gov, NCT01544257. PMID:23622070

Health Messaging and African-American Infant Sleep Location: A Randomized Controlled Trial.

PubMed

Moon, Rachel Y; Mathews, Anita; Joyner, Brandi L; Oden, Rosalind P; He, Jianping; McCarter, Robert

2017-02-01

Infant-parent bedsharing increases the risk of SIDS and other sleep-related deaths. Despite AAP recommendations to avoid bedsharing, public health efforts have been unsuccessful in changing behaviors. African-American infants are more than twice as likely to die from SIDS and other sleep-related deaths, and are also twice as likely to bedshare with their parents. Further, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation, but low self-efficacy with regards to SIDS risk reduction. It is unclear whether messages emphasizing suffocation prevention will decrease bedsharing. To evaluate the impact of specific health messages on African-American parental decisions regarding infant sleep location. We conducted a randomized, controlled trial of African-American mothers of infants. The control group received standard messaging emphasizing AAP-recommended safe sleep practices, including avoidance of bedsharing, for the purposes of SIDS risk reduction. The intervention group received enhanced messaging emphasizing safe sleep practices, including avoidance of bedsharing, for both SIDS risk reduction and suffocation prevention. Participants completed interviews at 2-3 weeks, 2-3 months, and 5-6 months after the infant's birth. 1194 mothers were enrolled in the study, and 637 completed all interviews. Bedsharing, both usually (aOR 1.005 [95 % CI 1.003, 1.006]) and last night (aOR 1.004 [95 % CI 1.002, 1.007]) increased slightly but statistically significantly with infant age (p < 0.001). Receipt of the enhanced message did not impact on sleep location. Maternal belief that bedsharing increased the risk of SIDS or suffocation declined over 6 months (p < 0.001) and did not differ by group assignment. African-American mothers who received an enhanced message about SIDS risk reduction and suffocation prevention were no less likely to bedshare with their infants. Clinical Trials.gov identifier NCT01361880.

Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

2012-01-01

Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

Parent involvement in pain management for NICU infants: a randomized controlled trial.

PubMed

Franck, Linda S; Oulton, Kate; Nderitu, Sue; Lim, Magdalene; Fang, Swee; Kaiser, Anthony

2011-09-01

To demonstrate feasibility and estimate the effect of an intervention to increase parental involvement in infant pain management in the NICU on parents' stress and postdischarge parenting competence and confidence. The study involved a randomized controlled trial. Parents recruited from 4 NICUs were randomly assigned by site to receive (1) a pain information booklet and instruction on infant comforting techniques (n = 84 intervention) in addition to a generic NICU care booklet or (2) the generic NICU care booklet alone (n = 85 control). The primary outcome was postintervention Parent Stressor Scale: NICU (PSS:NICU) scores. Secondary outcomes included parent attitudes about infant pain, nursing pain assessment, and parenting competence and role attainment after discharge. No differences were found between groups in PSS:NICU scores. Significant differences favoring the intervention group were found for satisfaction with pain information, parents shown infant pain cues and comforting techniques, nursing pain assessment, and parent preference for involvement during painful procedures. Role attainment after discharge was higher for the intervention group than for the control group. Both the intervention and control groups highly valued attention to infant pain and wanted information and involvement. These results provide no evidence of a reduction in NICU-related stress for parents who receive an intervention to increase their understanding and involvement in infant pain management. However, parents in the intervention group were better prepared to take an active role in infant pain care and had more positive views about their role attainment in the postdischarge period.

Glutamine Randomized Studies in Early Life: The Unsolved Riddle of Experimental and Clinical Studies

PubMed Central

Briassouli, Efrossini; Briassoulis, George

2012-01-01

Glutamine may have benefits during immaturity or critical illness in early life but its effects on outcome end hardpoints are controversial. Our aim was to review randomized studies on glutamine supplementation in pups, infants, and children examining whether glutamine affects outcome. Experimental work has proposed various mechanisms of glutamine action but none of the randomized studies in early life showed any effect on mortality and only a few showed some effect on inflammatory response, organ function, and a trend for infection control. Although apparently safe in animal models (pups), premature infants, and critically ill children, glutamine supplementation does not reduce mortality or late onset sepsis, and its routine use cannot be recommended in these sensitive populations. Large prospectively stratified trials are needed to better define the crucial interrelations of “glutamine-heat shock proteins-stress response” in critical illness and to identify the specific subgroups of premature neonates and critically ill infants or children who may have a greater need for glutamine and who may eventually benefit from its supplementation. The methodological problems noted in the reviewed randomized experimental and clinical trials should be seriously considered in any future well-designed large blinded randomized controlled trial involving glutamine supplementation in critical illness. PMID:23019424

Volvulus in term and preterm infants - clinical presentation and outcome.

PubMed

Horsch, Sandra; Albayrak, Bilge; Tröbs, Ralf-Bodo; Roll, Claudia

2016-06-01

Our aim was to assess if term and preterm infants with volvulus showed different patterns with regard to pathogenesis, clinical presentation and outcome. We reviewed the medical records and imaging data of infants aged less than six months with volvulus treated in a single surgical referral centre from 2006-2013. Volvulus was diagnosed in 19 infants, with no anatomical anomaly in three of the 12 preterm infants and one of the seven term infants. Most cases (74%) presented during the first eight days of life. Later presentations occurred exclusively in preterm infants, with only one of the five having no anatomic anomalies. Bilious vomiting was the leading symptom in six of the seven term infants, while the symptoms in preterm infants were rather nonspecific. Intestinal necrosis, with the need for bowel resection, occurred in one term (14%) infant and nine (75%) preterm infants. The clinical presentation and outcome of volvulus differed between preterm and term infants, but the rate and distribution of underlying anomalies did not differ. Symptoms in preterm infants were often nonspecific and led to a delay in diagnosis. This might have contributed to the higher rate of intestinal necrosis in preterm infants. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Effect of Early Physical Activity Programs on Motor Performance and Neuromuscular Development in Infants Born Preterm: A Randomized Clinical Trial

PubMed Central

Valizadeh, Leila; Sanaeefar, Mahnaz; Hosseini, Mohammad Bager; Asgari Jafarabadi, Mohammad; Shamili, Aryan

2017-01-01

Introduction: Although the survival rate of infants born preterm has increased, the prevalence of developmental problems and motor disorders among this population of infants remains the same. This study investigated the effect of physical activity programs in and out of water on motor performance and neuromuscular development of infants born preterm and had induced immobility by mechanical ventilation. Methods: This study was carried out in Al-Zahra hospital, Tabriz. 76 premature infants were randomly assigned into four groups. One group received daily passive range of motion to all extremities based on the Moyer-Mileur protocol. Hydrotherapy group received exercises for shoulders and pelvic area in water every other day. A combination group received physical activity programs in and out of water on alternating days. Infants in a containment group were held in a fetal position. Duration of study was two weeks ‘from 32 through 33 weeks post menstrual age (PMA). Motor outcomes were measured by the Test of Infant Motor Performance. Neuromuscular developmental was assessed by New Ballard scale and leg recoil and Ankle dorsiflexion items from Dubowitz scale. Data were analyzed using SPSS version 13. Results: TIMP and neuromuscular scores improved in all groups. Motor performance did not differ between groups at 34 weeks PMA. Postural tone of leg recoil was significantly higher in physical activity groups post intervention. Conclusion: Physical activities and containment didn’t have different effects on motor performance in infants born preterm. Leg recoil of neuromuscular development items was affected by physical activity programs. PMID:28299299

Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial.

PubMed

Savage, Jennifer S; Birch, Leann L; Marini, Michele; Anzman-Frasca, Stephanie; Paul, Ian M

2016-08-01

Rapid infant weight gain is associated with later obesity, but interventions to prevent rapid infant growth and reduce risk for overweight status in infancy are lacking. To examine the effect of a responsive parenting (RP) intervention on infant weight gain between birth and 28 weeks and overweight status at age 1 year. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study is an ongoing randomized clinical trial comparing an RP intervention designed to prevent childhood obesity with a safety control. The study includes primiparous mother-newborn dyads (n = 291) and was conducted at the Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, in addition to home visits. Enrollment was initiated in January 2012, and evaluable population analyses for this study were conducted between April 2015 and November 2015. At 2 weeks post partum, initial intervention materials appropriate to the assigned treatment group were mailed to the participant's home. Research nurses conducted home visits at 3 weeks, 16 weeks, 28 weeks, and 40 weeks, and a research center visit occurred at 1 year. The Intervention Nurses Start Infants Growing on Healthy Trajectories curriculum included messages about infant feeding, sleep hygiene, active social play, emotion regulation, and growth record education. The control group received a developmentally appropriate home safety intervention also delivered by nurse home visitors. Conditional weight gain from birth to 28 weeks was calculated. General linear models examined intervention effect on conditional weight gain. The intervention's effect on infant weight-for-length percentiles was tested using analysis of variance. Logistic regression compared the odds of overweight status (weight for length ≥95th percentile) at 1 year as a function of conditional weight gain. Of the mothers included in the study, 246 were white (88%), 260 were non-Hispanic (93%), 210 were married (75%), and 201 were working full

Preprocedural Ultrasound for Infant Lumbar Puncture: A Randomized Clinical Trial.

PubMed

Kessler, David; Pahalyants, Vartan; Kriger, Joshua; Behr, Gerald; Dayan, Peter

2018-04-12

Our purpose was to determine the potential effect of preprocedural ultrasound (US) to increase lumbar puncture (LP) success compared with standard palpation method. Further, we assessed feasibility of and clinician satisfaction with a standardized US protocol. This prospective, two-arm, parallel-group randomized trial was conducted in a single-center pediatric emergency department. We compared preprocedural US versus palpation method on success with infant LPs. Infants less than 3 months of age requiring LP were enrolled. Sixteen pediatric emergency medicine physicians with varied US experience were trained to conduct the USs to mark interspace locations. Primary outcome was successful LP, defined as obtaining a cerebrospinal fluid (CSF) sample on first attempt with < 1,000 red blood cells per high-powered field (clear CSF). Secondary outcomes included clear CSF on any attempt, any CSF on the first attempt, traumatic LP proportion, and LP attempt frequency. Feasibility was assessed by comparing provider number attempting the LP and procedure duration. Clinician satisfaction and sonographer perceptions of US acceptability and impact were assessed. Eighty-one patients consented and 80 were analyzed (99%): 40 per group. No statistical difference was seen for the primary outcome (p > 0.05) between intervention and control groups (difference 3%; 95% confidence interval = -19% to 24%). There were no statistical differences between intervention and controls groups for secondary outcomes including the rate of traumatic LPs, number of attempts, and the duration of LP procedure. Most sonographers (84%) strongly agreed or agreed that the US protocol was technically easy to perform, well tolerated by the patient (94%), well accepted by the family (100%), and well accepted by the LP procedural clinicians (99%). In the US group, the majority of clinicians who performed the LPs (68.4%) noted that the preprocedural US influenced their behavior, most commonly helping with

Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

PubMed Central

Gay, Caryl L.; Lynch, Mary; Lee, Kathryn A.

2011-01-01

OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration. PMID:22123869

Dietary nucleotides and early growth in formula-fed infants: a randomized controlled trial.

PubMed

Singhal, Atul; Kennedy, Kathy; Lanigan, J; Clough, Helen; Jenkins, Wendy; Elias-Jones, Alun; Stephenson, Terrence; Dudek, Peter; Lucas, Alan

2010-10-01

Dietary nucleotides are nonprotein nitrogenous compounds that are found in high concentrations in breast milk and are thought to be conditionally essential nutrients in infancy. A high nucleotide intake has been suggested to explain some of the benefits of breastfeeding compared with formula feeding and to promote infant growth. However, relatively few large-scale randomized trials have tested this hypothesis in healthy infants. We tested the hypothesis that nucleotide supplementation of formula benefits early infant growth. Occipitofrontal head circumference, weight, and length were assessed in infants who were randomly assigned to groups fed nucleotide-supplemented (31 mg/L; n=100) or control formula without nucleotide supplementation (n=100) from birth to the age of 20 weeks, and in infants who were breastfed (reference group; n=101). Infants fed with nucleotide-supplemented formula had greater occipitofrontal head circumference at ages 8, 16, and 20 weeks than infants fed control formula (mean difference in z scores at 8 weeks: 0.4 [95% confidence interval: 0.1-0.7]; P=.006) even after adjustment for potential confounding factors (P=.002). Weight at 8 weeks and the increase in both occipitofrontal head circumference and weight from birth to 8 weeks were also greater in infants fed nucleotide-supplemented formula than in those fed control formula. Our data support the hypothesis that nucleotide supplementation leads to increased weight gain and head growth in formula-fed infants. Therefore, nucleotides could be conditionally essential for optimal infant growth in some formula-fed populations. Additional research is needed to test the hypothesis that the benefits of nucleotide supplementation for early head growth, a critical period for brain growth, have advantages for long-term cognitive development.

Postnatal fish oil supplementation in high-risk infants to prevent allergy: randomized controlled trial.

PubMed

D'Vaz, N; Meldrum, S J; Dunstan, J A; Martino, D; McCarthy, S; Metcalfe, J; Tulic, M K; Mori, T A; Prescott, S L

2012-10-01

Relative deficiency of dietary omega 3 polyunsaturated fatty acids (n-3 PUFA) has been implicated in the rising allergy prevalence in Westernized countries. Fish oil supplementation may provide an intervention strategy for primary allergy prevention. The objective of this study was to assess the effect of fish oil n-3 PUFA supplementation from birth to 6 months of age on infant allergic disease. In a double-blind randomized controlled trial, 420 infants at high atopic risk received a daily supplement of fish oil containing 280 mg docosahexaenoic acid and 110 mg eicosapentaenoic acid or a control (olive oil), from birth to age 6 months. PUFA levels were measured in 6-month-old infants' erythrocytes and plasma and their mothers' breast milk. Eczema, food allergy, asthma and sensitization were assessed in 323 infants for whom clinical follow-up was completed at 12 months of age. At 6 months of age, infant docosahexaenoic acid and eicosapentaenoic acid levels were significantly higher (both P < .05) and erythrocyte arachidonic acid levels were lower (P = .003) in the fish oil group. Although n-3 PUFA levels at 6 months were associated with lower risk of eczema (P = .033) and recurrent wheeze (P = .027), the association with eczema was not significant after multiple comparisons and there was no effect of the intervention per se on the primary study outcomes. Specifically, between-group comparisons revealed no differences in the occurrence of allergic outcomes including sensitization, eczema, asthma, or food allergy. Postnatal fish oil supplementation improved infant n-3 status but did not prevent childhood allergic disease.

Insightfulness and later infant attachment in clinically depressed and nonclinical mothers.

PubMed

Ramsauer, Brigitte; Lotzin, Annett; Quitmann, Julia H; Becker-Stoll, Fabienne; Tharner, Anne; Romer, Georg

2014-01-01

The aim of this pilot study was to investigate the relationship between maternal insightfulness and sensitivity and subsequent infant attachment security and disorganization in clinically depressed and nonclinical mother-infant groups. Nineteen depressed mothers with infants ages 3 to 11 months participated in this study. Twenty nonclinical mother-infant dyads were matched to the clinical sample according to infant sex and age. Maternal depression was assessed using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (American Psychiatric Association, 1994), insightfulness using the Insightfulness Assessment (IA), and sensitivity using the Maternal Sensitivity Scales (M.D.S. Ainsworth, 1969). IA classifications and subscales were considered separately. Later infant attachment was assessed by the Strange Situation Procedure (M.D.S. Ainsworth, M.C. Blehar, E. Waters, & S. Wall, 1978). Depressed mothers tended to have less securely attached children than did nonclinical mothers. Within the clinical sample, the insightfulness categories correlated slightly moderately with attachment security, but were not related to attachment disorganization. Within the nonclinical sample, the IA categories were slightly moderately associated with attachment security and with disorganization. On IA subscales, relationship patterns differed in clinically depressed and nonclinical mother-infant dyads. These findings provide the first evidence of the predictive power of the IA categorization and subscales on subsequent infant attachment. They also may allow the development of different foci of intervention for enhancing insightful caregiving. © 2014 Michigan Association for Infant Mental Health.

Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial.

PubMed

Nowacki, Joyce; Lee, Hung-Chang; Lien, Reyin; Cheng, Shao-Wen; Li, Sung-Tse; Yao, Manjiang; Northington, Robert; Jan, Ingrid; Mutungi, Gisella

2014-11-05

Formula-fed (FF) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants. Feeding high sn-2 palmitate or the prebiotic oligofructose (OF) may soften stools, reduce stool soaps, and decrease fecal calcium loss. We investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap, total soap and calcium concentrations, stool consistency, gastrointestinal (GI) tolerance, anthropometrics, and hydration in FF infants. This double-blind trial randomized 165 healthy term infants 25-45 days old to receive Control formula (n = 54), formula containing high sn-2 palmitate (sn-2; n = 56), or formula containing high sn-2 palmitate plus 3 g/L OF (sn-2+OF; n = 55). A non-randomized human milk (HM)-fed group was also included (n = 55). The primary endpoint, stool composition, was determined after 28 days of feeding, and was assessed using ANOVA accompanied by pairwise comparisons. Stool consistency, GI tolerance and hydration were assessed at baseline, day 14 (GI tolerance only) and day 28. Infants fed sn-2 had lower stool palmitate soaps compared to Control (P = 0.0028); while those fed sn-2+OF had reduced stool palmitate soaps compared to both Control and sn-2 (both P < 0.0001). Stool total soaps and calcium were lower in the sn-2+OF group than either Control (P < 0.0001) or sn-2 (P < 0.0001). The HM-fed group had lower stool palmitate soaps, total soaps and calcium (P < 0.0001 for each comparison) than all FF groups. The stool consistency score of the sn-2+OF group was lower than Control and sn-2 (P < 0.0001), but higher than the HM-fed group (P < 0.0001). GI tolerance was similar and anthropometric z-scores were <0.2 SD from the WHO growth standards in all groups, while urinary hydration markers were within normal range for all FF infants. Increasing sn-2 palmitate in infant formula reduces stool palmitate soaps. A combination of high sn-2 palmitate and OF reduces

Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

PubMed Central

2009-01-01

Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program

Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.

PubMed

Kristoffersen, Laila; Støen, Ragnhild; Rygh, Hilde; Sognnæs, Margunn; Follestad, Turid; Mohn, Hilde S; Nissen, Ingrid; Bergseng, Håkon

2016-12-12

Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at St. Olav's University Hospital. In the present study we aim to investigate whether skin-to-skin care following delivery is safe, and how it affects early and late outcomes compared to standard care for very preterm infants. A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 28 0 -31 6 weeks with birth weight >1000 grams. Infants with severe congenital malformations or need of intubation in the delivery room are excluded. A detailed checklist and a flowchart were prepared for the study, and all involved professionals (neonatologists, neonatal nurses, obstetricians, anesthesiologists, midwives) participated in medical simulation training prior to study start on February 1, 2014. A consultant in neonatology and a neonatal nurse are present at all deliveries. Infants with birth weight <1500 grams receive an intravenous line with glucose, amino acids, and caffeine citrate in the delivery room. Infants with gestational age <30 weeks are routinely put on continuous positive airway pressure (CPAP). After initial stabilization, infants are randomized to skin-to-skin care or are transferred to the nursery in an incubator. Primary outcome is cognitive development at 2 years measured with the Bayley Scales of Infant Development, Third Edition. Secondary outcomes are safety defined as hypothermia, respiratory failure, and/or cardiopulmonary resuscitation, physiological stability after birth and motor, language and cognitive development at 1 year for the child, and mental health measured with the State-Trait Anxiety Inventory (STAI) at discharge, and at 3 months and 2�

Comparison of 2 Dosages of Stretching Treatment in Infants with Congenital Muscular Torticollis: A Randomized Trial.

PubMed

He, Lu; Yan, Xiaohua; Li, Jinling; Guan, Buyun; Ma, Liying; Chen, Ying; Mai, Jianning; Xu, Kaishou

2017-05-01

To compare the short-term efficacy of 2 dosages of stretching treatment on the clinical outcomes in infants with congenital muscular torticollis. This was a prospective randomized controlled study. Fifty infants with congenital muscular torticollis who were randomly assigned to 100-times stretching group and 50-times stretching group received stretching treatment for the affected sternocleidomastoid muscle. The outcomes including the head tilt, the cervical passive range of motion, and the muscle function of cervical lateral flexors determined by the muscle function scale were assessed at baseline and at 4 and 8 weeks after treatment. The sternocleidomastoid muscle growth analyzed by the thickness ratio of sternocleidomastoid muscles was measured using ultrasonography at baseline and 8 weeks after treatment. Except the ratio of muscle function scale scores, the postintervention outcomes were all significantly improved in both groups compared with baseline (P < 0.05). The 100-times stretching group showed greater improvement compared with 50-times stretching group in head tilt and cervical passive range of motion at 4 and 8 weeks after treatment (P < 0.05). Stretching treatment of 2 dosages may effectively improve head tilt, cervical passive range of motion, and sternocleidomastoid muscle growth in infants with congenital muscular torticollis. The stretching treatment of 100 times per day is likely to associate with greater improvement in head tilt and cervical passive range of motion.

Infants' social withdrawal symptoms assessed with a direct infant observation method in primary health care.

PubMed

Puura, Kaija; Mäntymaa, Mirjami; Luoma, Ilona; Kaukonen, Pälvi; Guedeney, Antoine; Salmelin, Raili; Tamminen, Tuula

2010-12-01

Distressed infants may withdraw from social interaction, but recognising infants' social withdrawal is difficult. The aims of the study were to see whether an infant observation method can be reliably used by front line workers, and to examine the prevalence of infants' social withdrawal symptoms. A random sample of 363 families with four, eight or 18-month-old infants participated in the study. The infants were examined by general practitioners (GPs) in well-baby clinics with the Alarm Distress BaBy Scale (ADBB), an observation method developed for clinical settings. A score of five or more on the ADBB Scale in two subsequent assessments at a two-week interval was regarded as a sign of clinically significant infant social withdrawal. Kappas were calculated for the GPs' correct rating of withdrawn/not withdrawn against a set of videotapes rated by developer of the method, Professor Guedeney and his research group. The kappas for their ratings ranged from 0.5 to 1. The frequency of infants scoring above the cut off in two subsequent assessments was 3%. The ADBB Scale is a promising method for detecting infant social withdrawal in front line services. Three percents of infants were showing sustained social withdrawal as a sign of distress in this normal population sample. Copyright © 2010 Elsevier Inc. All rights reserved.

Clinical signs of dysphagia in infants with acute viral bronchiolitis☆

PubMed Central

Barbosa, Lisiane De Rosa; Gomes, Erissandra; Fischer, Gilberto Bueno

2014-01-01

Objective: To determine the occurrence of clinical signs of dysphagia in infants with acute viral bronchiolitis, to compare the respiratory parameters during deglutition, and to ensure the intra- and inter- examiners agreement, as well as to accomplish intra and interexaminators concordance of the clinical evaluation of the deglutition. Methods: This was a cross-sectional study of 42 infants aged 0-12 months. The clinical evaluation was accompanied by measurements of respiratory rate and pulse oximetry. A score of swallowing disorders was designed to establish associations with other studied variables and to ensure the intra- and interrater agreement of clinical feeding assessments. Caregivers also completed a questionnaire about feeding difficulties. Significance was set at p<0.05. Results: Changes in the oral phase (prolonged pauses) and pharyngeal phase (wheezing, coughing and gagging) of swallowing were found. A significant increase in respiratory rate between pre- and post-feeding times was found, and it was determined that almost half of the infants had tachypnea. An association was observed between the swallowing disorder scores and a decrease in oxygen saturation. Infants whose caregivers reported feeding difficulties during hospitalization stated a significantly greater number of changes in the swallowing evaluation. The intra-rater agreement was considered to be very good. Conclusions: Infants with acute viral bronchiolitis displayed swallowing disorders in addition to changes in respiratory rate and measures of oxygen saturation. It is suggested, therefore, that infants displaying these risk factors have a higher probability of dysphagia. PMID:25479843

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

PubMed Central

2012-01-01

Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention

Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial.

PubMed

Schmidt, Barbara; Whyte, Robin K; Asztalos, Elizabeth V; Moddemann, Diane; Poets, Christian; Rabi, Yacov; Solimano, Alfonso; Roberts, Robin S

2013-05-22

The goal of oxygen therapy is to deliver sufficient oxygen to the tissues while minimizing oxygen toxicity and oxidative stress. It remains uncertain what values of arterial oxygen saturations achieve this balance in preterm infants. To compare the effects of targeting lower or higher arterial oxygen saturations on the rate of death or disability in extremely preterm infants. Randomized, double-blind trial in 25 hospitals in Canada, the United States, Argentina, Finland, Germany, and Israel in which 1201 infants with gestational ages of 23 weeks 0 days through 27 weeks 6 days were enrolled within 24 hours after birth between December 2006 and August 2010. Follow-up assessments began in October 2008 and ended in August 2012. Study participants were monitored until postmenstrual ages of 36 to 40 weeks with pulse oximeters that displayed saturations of either 3% above or below the true values. Caregivers adjusted the concentration of oxygen to achieve saturations between 88% and 92%, which produced 2 treatment groups with true target saturations of 85% to 89% (n = 602) or 91% to 95% (n = 599). Alarms were triggered when displayed saturations decreased to 86% or increased to 94%. The primary outcome was a composite of death, gross motor disability, cognitive or language delay, severe hearing loss, or bilateral blindness at a corrected age of 18 months. Secondary outcomes included retinopathy of prematurity and brain injury. Of the 578 infants with adequate data for the primary outcome who were assigned to the lower target range, 298 (51.6%) died or survived with disability compared with 283 of the 569 infants (49.7%) assigned to the higher target range (odds ratio adjusted for center, 1.08; 95% CI, 0.85 to 1.37; P = .52). The rates of death were 16.6% for those in the 85% to 89% group and 15.3% for those in the 91% to 95% group (adjusted odds ratio, 1.11; 95% CI, 0.80 to 1.54; P = .54). Targeting lower saturations reduced the postmenstrual age at last use of oxygen

Evaluation of a newly developed infant chest compression technique: A randomized crossover manikin trial.

PubMed

Smereka, Jacek; Bielski, Karol; Ladny, Jerzy R; Ruetzler, Kurt; Szarpak, Lukasz

2017-04-01

Providing adequate chest compression is essential during infant cardio-pulmonary-resuscitation (CPR) but was reported to be performed poor. The "new 2-thumb technique" (nTTT), which consists in using 2 thumbs directed at the angle of 90° to the chest while closing the fingers of both hands in a fist, was recently introduced. Therefore, the aim of this study was to compare 3 chest compression techniques, namely, the 2-finger-technique (TFT), the 2-thumb-technique (TTHT), and the nTTT in an randomized infant-CPR manikin setting. A total of 73 paramedics with at least 1 year of clinical experience performed 3 CPR settings with a chest compression:ventilation ratio of 15:2, according to current guidelines. Chest compression was performed with 1 out of the 3 chest compression techniques in a randomized sequence. Chest compression rate and depth, chest decompression, and adequate ventilation after chest compression served as outcome parameters. The chest compression depth was 29 (IQR, 28-29) mm in the TFT group, 42 (40-43) mm in the TTHT group, and 40 (39-40) mm in the nTTT group (TFT vs TTHT, P < 0.001; TFT vs nTTT, P < 0.001; TTHT vs nTTT, P < 0.01). The median compression rate with TFT, TTHT, and nTTT varied and amounted to 136 (IQR, 133-144) min versus 117 (115-121) min versus 111 (109-113) min. There was a statistically significant difference in the compression rate between TFT and TTHT (P < 0.001), TFT and nTTT (P < 0.001), as well as TTHT and nTTT (P < 0.001). Incorrect decompressions after CC were significantly increased in the TTHT group compared with the TFT (P < 0.001) and the nTTT (P < 0.001) group. The nTTT provides adequate chest compression depth and rate and was associated with adequate chest decompression and possibility to adequately ventilate the infant manikin. Further clinical studies are necessary to confirm these initial findings.

Office-based treatment and outcomes for febrile infants with clinically diagnosed bronchiolitis.

PubMed

Luginbuhl, Lynn M; Newman, Thomas B; Pantell, Robert H; Finch, Stacia A; Wasserman, Richard C

2008-11-01

The goals were to describe the (1) frequency of sepsis evaluation and empiric antibiotic treatment, (2) clinical predictors of management, and (3) serious bacterial illness frequency for febrile infants with clinically diagnosed bronchiolitis seen in office settings. The Pediatric Research in Office Settings network conducted a prospective cohort study of 3066 febrile infants (<3 months of age with temperatures >or=38 degrees C) in 219 practices in 44 states. We compared the frequency of sepsis evaluation, parenteral antibiotic treatment, and serious bacterial illness in infants with and without clinically diagnosed bronchiolitis. We identified predictors of sepsis evaluation and parenteral antibiotic treatment in infants with bronchiolitis by using logistic regression models. Practitioners were less likely to perform a complete sepsis evaluation, urine testing, and cerebrospinal fluid culture and to administer parenteral antibiotic treatment for infants with bronchiolitis, compared with those without bronchiolitis. Significant predictors of sepsis evaluation in infants with bronchiolitis included younger age, higher maximal temperature, and respiratory syncytial virus testing. Predictors of parenteral antibiotic use included initial ill appearance, age of <30 days, higher maximal temperature, and general signs of infant distress. Among infants with bronchiolitis (N = 218), none had serious bacterial illness and those with respiratory distress signs were less likely to receive parenteral antibiotic treatment. Diagnoses among 2848 febrile infants without bronchiolitis included bacterial meningitis (n = 14), bacteremia (n = 49), and urinary tract infection (n = 167). In office settings, serious bacterial illness in young febrile infants with clinically diagnosed bronchiolitis is uncommon. Limited testing for bacterial infections seems to be an appropriate management strategy.

PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi.

PubMed

Njuguna, Irene N; Ambler, Gwen; Reilly, Marie; Ondondo, Beatrice; Kanyugo, Mercy; Lohman-Payne, Barbara; Gichuhi, Christine; Borthwick, Nicola; Black, Antony; Mehedi, Shams-Rony; Sun, Jiyu; Maleche-Obimbo, Elizabeth; Chohan, Bhavna; John-Stewart, Grace C; Jaoko, Walter; Hanke, Tomáš

2014-10-07

A safe, effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy (ART) for prevention of mother-to-child transmission of HIV-1. To date, only a few HIV-1 vaccine candidates have been tested in infants. A phase I/II randomized controlled trial PedVacc 002 was conducted to determine the safety and immunogenicity of a single, low dose of MVA.HIVA vaccine delivered intramuscularly to healthy 20-week-old infants born to HIV-1-positive mothers in Nairobi, Kenya. Pregnant HIV-1-positive women in the 2nd/3rd trimester of gestation were enrolled, provided with ART and self-selected their infant-feeding modality. Infants received nevirapine and cotrimoxazole prophylaxis. At 20 weeks of age, eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety, HIV-1-specific T-cell responses and antibodies to routine childhood vaccines. Between February and November 2010, 182 mothers were screened, 104 were eligible and followed on ART during pregnancy/postpartum, of whom 73 had eligible infants at 20 weeks postpartum. Thirty-six infants were randomized to vaccine and 37 to no treatment. Eighty-four percent of infants breastfed, and retention at 48 weeks was 99%. Adverse events were rare and similar between the two arms. HIV-1-specific T-cell frequencies in interferon-γ ELISPOT assay were transiently higher in the MVA.HIVA arm (p=0.002), but not above the threshold for a positive assay. Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV, where 71% of MVA.HIVA subjects compared to 92% of control subjects were protected (p=0.05). This trial tested for the first time an MVA-vectored candidate HIV-1 vaccine in HIV-1-exposed infants in Africa, demonstrating trial feasibility and vaccine safety, low immunogenicity, and compatibility with routine childhood vaccinations. These results

[Clinical signs of dysphagia in infants with acute viral bronchiolitis].

PubMed

Barbosa, Lisiane De Rosa; Gomes, Erissandra; Fischer, Gilberto Bueno

2014-09-01

To determine the occurrence of clinical signs of dysphagia in infants with acute viral bronchiolitis, to compare the respiratory parameters during deglutition, and to ensure the intra- and inter- examiners agreement, as well as to accomplish intra and interexaminators concordance of the clinical evaluation of the deglutition. This was a cross-sectional study of 42 infants aged 0-12 months. The clinical evaluation was accompanied by measurements of respiratory rate and pulse oximetry. A score of swallowing disorders was designed to establish associations with other studied variables and to ensure the intra- and interrater agreement of clinical feeding assessments. Caregivers also completed a questionnaire about feeding difficulties. Significance was set at p<0.05. Changes in the oral phase (prolonged pauses) and pharyngeal phase (wheezing, coughing and gagging) of swallowing were found. A significant increase in respiratory rate between pre- and post-feeding times was found, and it was determined that almost half of the infants had tachypnea. An association was observed between the swallowing disorder scores and a decrease in oxygen saturation. Infants whose caregivers reported feeding difficulties during hospitalization stated a significantly greater number of changes in the swallowing evaluation. The intra-rater agreement was considered to be very good. Infants with acute viral bronchiolitis displayed swallowing disorders in addition to changes in respiratory rate and measures of oxygen saturation. It is suggested, therefore, that infants displaying these risk factors have a higher probability of dysphagia. Copyright © 2014 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

Randomized trial of occlusive wrap for heat loss prevention in preterm infants.

PubMed

Reilly, Maureen C; Vohra, Sunita; Rac, Valeria E; Dunn, Michael; Ferrelli, Karla; Kiss, Alex; Vincer, Michael; Wimmer, John; Zayack, Denise; Soll, Roger F

2015-02-01

To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants. This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks' gestation who were assigned randomly to occlusive wrap or no wrap. The primary outcome was all cause mortality at discharge or 6 months' corrected age. Secondary outcomes included temperature, Apgar scores, pH, base deficit, blood pressure and glucose, respiratory distress syndrome, bronchopulmonary dysplasia, seizures, patent ductus arteriosus, necrotizing enterocolitis, gastrointestinal perforation, intraventricular hemorrhage, cystic periventricular leukomalacia, pulmonary hemorrhage, retinopathy of prematurity, sepsis, hearing screen, and pneumothorax. Eight hundred one infants were enrolled. There was no difference in baseline population characteristics. There were no significant differences in mortality (OR 1.0, 95% CI 0.7-1.5). Wrap infants had statistically significant greater baseline temperatures (36.3°C wrap vs 35.7°C no wrap, P < .0001) and poststabilization temperatures (36.6°C vs 36.2°C, P < .001) than nonwrap infants. For the secondary outcomes, there was a significant decrease in pulmonary hemorrhage (OR 0.6, 95% CI 0.3-0.9) in the wrap group and a significant lower mean one minute Apgar score (P = .007) in the wrap group. The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome. Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi

PubMed Central

Muhammad, Amber A.; Shafiq, Yasir; Shah, Saima; Kumar, Naresh; Ahmed, Imran; Azam, Iqbal; Pasha, Omrana; Zaidi, Anita K. M.

2017-01-01

Abstract Background. Integrated Management of Childhood Illness recommends that young infants with isolated fast breathing be referred to a hospital for antibiotic treatment, which is often impractical in resource-limited settings. Additionally, antibiotics may be unnecessary for physiologic tachypnea in otherwise well newborns. We tested the hypothesis that ambulatory treatment with oral amoxicillin for 7 days was equivalent (similarity margin of 3%) to placebo in young infants with isolated fast breathing in primary care settings where hospital referral is often unfeasible. Methods. This randomized equivalence trial was conducted in 4 primary health centers of Karachi, Pakistan. Infants presenting with isolated fast breathing and oxygen saturation ≥90% were randomly assigned to receive either oral amoxicillin or placebo twice daily for 7 days. Enrolled infants were followed on days 1–8, 11, and 14. The primary outcome was treatment failure by day 8, analyzed per protocol. The trial was stopped by the data safety monitoring board due to higher treatment failure rate and the occurrence of 2 deaths in the placebo arm in an interim analysis. Results. Four hundred twenty-three infants fulfilled per protocol criteria in the amoxicillin arm and 426 in the placebo arm. Twelve infants (2.8%) had treatment failure in the amoxicillin arm and 25 (5.9%) in the placebo arm (risk difference, 3.1; P value .04). Two infants in the placebo arm died, whereas no deaths occurred in the amoxicillin arm. Other adverse outcomes, as well as the proportions of relapse, were evenly distributed across both study arms. Conclusions. This trial failed to show equivalence of placebo to amoxicillin in the management of isolated fast breathing without hypoxemia or other clinical signs of illness in term young infants. Clinical Trials Registration. NCT01533818. PMID:27941119

Assessment of complementary feeding of Canadian infants: effects on microbiome & oxidative stress, a randomized controlled trial.

PubMed

Qasem, Wafaa; Azad, Meghan B; Hossain, Zakir; Azad, Elnaz; Jorgensen, Sarah; Castillo San Juan, Sandra; Cai, Chenxi; Khafipour, Ehsan; Beta, Trust; Roberts, L Jackson; Friel, James

2017-02-14

The World Health Organization recommends exclusive breastfeeding until 6 months followed by introduction of iron-rich complementary foods (CFs). The aim of this study was to determine the impact of different iron-rich CFs on infant gut inflammation and microbiota. Eighty-seven exclusively breastfed infants were randomly assigned to receive one of the following as their first CF: iron-fortified cereal (Cer), iron-fortified cereal with fruit (Cer + Fr), or meat (M). Urine and stool samples were collected to assess reactive oxygen species (ROS) generation, gut microbiota and inflammation. Fecal iron differed across feeding groups (p < 0.001); levels were highest in the Cer group and lowest in M group. A significant increase of fecal ROS formation (p < 0.002) after the introduction of CFs was observed, but did not differ across feeding groups. Fecal calprotectin increased within all groups after the introduction of CFs (p = 0.004). Gut microbiota richness increased after introduction of M or Cer + Fr. Regardless of feeding group, Coriobacteriaceae were positively correlated with ROS and Staphylococcaceae were negatively correlated with calprotectin. Choice of first CF may influence gut inflammation and microbiota, potentially due to variations in iron absorption from different foods. Further research is warranted to fully characterize these associations and to establish implications for infant health. This study was registered in the ClinicalTrial.gov registry (Identifier No. NCT01790542 ). This study was registered in the ClinicalTrial.gov registry under the name "Assessment of Complementary Feeding of Canadian Infants" (Identifier No. NCT01790542 ) February 6, 2013.

Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants: Randomized Controlled Trial

PubMed Central

Maron, Jill Lamanna; Alterovitz, Gil; Song, Dongli; Wilson, Bernard Joseph; Jegatheesan, Priya; Govindaswami, Balaji; Lee, Jaehoon; Rosner, Austin Oder

2017-01-01

randomized to receive either PULSED or SHAM (non-pulsing) orocutaneous intervention simultaneous with tube feedings 3 times per day for 4 weeks, beginning at 30 weeks postconceptional age. Infants will also be assessed 3 times per week for NNS performance, and multiple saliva samples will be obtained each week for transcriptomic analysis, until infants have achieved full oral feeding status. At 18 months corrected age (CA), infants will undergo neurodevelopmental follow-up testing, the results of which will be correlated with feeding outcomes in the neo-and post-natal period and with gene expression data and intervention status. Results The ongoing National Institutes of Health funded randomized controlled trial R01HD086088 is actively recruiting participants. The expected completion date of the study is 2021. Conclusions Differential salivary gene expression profiles in response to orosensory entrainment intervention are expected to lead to the development of individualized interventions for the diagnosis and management of oral feeding in preterm infants. Trial Registration ClinicalTrials.gov NCT02696343; https://clinicaltrials.gov/ct2/show/NCT02696343 (Archived by WebCite at http://www.webcitation.org/6r5NbJ9Ym) PMID:28615158

Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial.

PubMed

Bueno, Mariana; Stevens, Bonnie; de Camargo, Patrícia Ponce; Toma, Edi; Krebs, Vera Lúcia Jornada; Kimura, Amélia Fumiko

2012-04-01

The study goal was to compare the efficacy of expressed breast milk (EBM) versus 25% glucose on pain responses of late preterm infants during heel lancing. In a noninferiority randomized controlled trial, a total of 113 newborns were randomized to receive EBM (experimental group [EG]) or 25% glucose (control group [CG]) before undergoing heel lancing. The primary outcome was pain intensity (Premature Infant Pain Profile [PIPP]) and a 10% noninferiority margin was established. Secondary outcomes were incidence of cry and percentage of time spent crying and adverse events. Intention-to-treat (ITT) analysis was used. Groups were similar regarding demographics and clinical characteristics, except for birth weight and weight at data collection day. There were lower pain scores in the CG over 3 minutes after lancing (P < .001). A higher number of infants in the CG had PIPP scores indicative of minimal pain or absence of pain (P = .002 and P = .003 on ITT analysis) at 30 seconds after lancing, and the mean difference in PIPP scores was 3 (95% confidence interval: 1.507-4.483). Lower incidence of cry (P = .001) and shorter duration of crying (P = .014) were observed for CG. Adverse events were benign and self-limited, and there was no significant difference between groups (P = .736 and P = .637 on ITT analysis). Results based on PIPP scores and crying time indicate poorer effects of EBM compared with 25% glucose during heel lancing. Additional studies exploring the vol and administration of EBM and its combination with other strategies such as skin-to-skin contact and sucking are necessary.

Response to Infant Cry in Clinically Depressed and Non-Depressed Mothers

PubMed Central

Manian, Nanmathi; Truzzi, Anna; Bornstein, Marc H.

2017-01-01

Background Bowlby and Ainsworth hypothesized that maternal responsiveness is displayed in the context of infant distress. Depressed mothers are less responsive to infant distress vocalizations (cry) than non-depressed mothers. The present study focuses on acoustical components of infant cry that give rise to responsive caregiving in clinically depressed (n = 30) compared with non-depressed mothers (n = 30) in the natural setting of the home. Methods Analyses of infant and mother behaviors followed three paths: (1) tests of group differences in acoustic characteristics of infant cry, (2) tests of group differences of mothers’ behaviors during their infant’s crying, and (3) tree-based modeling to ascertain which variable(s) best predict maternal behaviors during infant cry. Results (1) Infants of depressed mothers cried as frequently and for equal durations as infants of non-depressed mothers; however, infants of depressed mothers cried with a higher fundamental frequency (f0) and in a more restricted range of f0. (2) Depressed mothers fed, rocked, and touched their crying infants less than non-depressed mothers, and depressed mothers were less responsive to their infants overall. (3) Novel tree-based analyses confirmed that depressed mothers engaged in less caregiving during their infants’ cry and indicated that depressed mothers responded only to cries at higher f0s and shorter durations. Older non-depressed mothers were the most interactive with infants. Conclusions Clinical depression affects maternal responsiveness during infant cry, leading to patterns of action that appear poorly attuned to infant needs. PMID:28046020

A randomized controlled trial of post-extubation bubble continuous positive airway pressure versus Infant Flow Driver continuous positive airway pressure in preterm infants with respiratory distress syndrome.

PubMed

Gupta, Samir; Sinha, Sunil K; Tin, Win; Donn, Steven M

2009-05-01

To compare the efficacy and safety of bubble continuous positive airway pressure (CPAP) and Infant Flow Driver (IFD) CPAP for the post-extubation management of preterm infants with respiratory distress syndrome (RDS). A total of 140 preterm infants at 24 to 29 weeks' gestation or with a birth weight of 600 to 1500 g who were ventilated at birth for RDS were randomized to receive either IFD CPAP (a variable-flow device) or bubble CPAP (a continuous-flow device). A standardized protocol was used for extubation and CPAP. No crossover was allowed. The primary outcome was successful extubation maintained for at least 72 hours. Secondary outcomes included successful extubation maintained for 7 days, total duration of CPAP support, chronic lung disease, and complications of prematurity. Seventy-one infants were randomized to bubble CPAP, and 69 were randomized to IFD CPAP. Mean gestational age and birth weight were similar in the 2 groups, as were the proportions of infants who achieved successful extubation for 72 hours and for 7 days. However, the median duration of CPAP support was 50% shorter in the infants on bubble CPAP. Moreover, in the subset of infants who were ventilated for less than 14 days, the infants on bubble CPAP had a significantly lower extubation failure rate. There was no difference in the incidence of chronic lung disease or other complications between the 2 study groups. Bubble CPAP is as effective as IFD CPAP in the post-extubation management of infants with RDS; however, in infants ventilated for < or = 14 days, bubble CPAP is associated with a significantly higher rate of successful extubation. Bubble CPAP also is associated with a significantly reduced duration of CPAP support.

[TREATMENT OF EXTREMELY PREMATURE NEWBORN INFANT WITH INO. CLINICAL CASE].

PubMed

Radulova, P; Slancheva, B; Marinov, R

2015-01-01

Prolonged inhaled nitric oxide (iNO) from birth in preterm neonates with BPD improves endogenous surfactant function as well as lung growth, angiogenesis, and alveologenesis. As a result there is a reduction in the frequency of the "new" form of BPD in neonates under 28 weeks of gestation and birth weight under 1000 gr. Delivery of inhaled nitric oxide is a new method of prevention of chronic lung disease. According to a large number of randomized trials iNO in premature neonates reduces pulmonary morbidity and leads to a reduction of the mortality in this population of patients. This new therapy does not have serious side effects. We represent a clinical case of extremely premature newborn infant with BPD treated with iNO.

Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial.

PubMed

Alipour, Zahra; Eskandari, Narges; Ahmari Tehran, Hoda; Eshagh Hossaini, Seyed Kamal; Sangi, Sareh

2013-08-01

Despite persuasive theories about the beneficial effects of music and singing in developmental care for premature infants, few small studies are available in this regard. We conducted this study to investigate the physiological and behavioral responses of premature infants to recorded lullaby music and silence. In a randomized controlled trial, 90 premature infants in the neonatal care unit of a hospital in Qom (Iran) were randomly allocated to intervention (lullaby and silence) or control groups. Lullaby music was played via headphones at a volume of 50-60 dB. In the silence group, headphones were placed on the infants' ears while no music was played. The three groups were surveyed for physiological responses including oxygen saturation, respiratory and heart rates, and behavioral states every five minutes before, during, and after the intervention. The three groups were not significantly different in terms of mean values of respiratory and heart rates, oxygen saturation, and behavioral states of infants. Similarly, no significant within group differences in respiratory and heart rates, oxygen saturation, and behavioral states were observed at different times. Our findings did not support the beneficial effects of music for premature infants. However, music is a noninvasive, non-pharmaceutical, and relatively low-cost intervention that can be implemented at infants' bedside. Thus further research is warranted to determine whether the effects noted in previous studies can be consistently replicated in diverse settings and with diverse groups of preterm infants. Copyright © 2013 Elsevier Ltd. All rights reserved.

Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery.

PubMed

Newburger, Jane W; Jonas, Richard A; Soul, Janet; Kussman, Barry D; Bellinger, David C; Laussen, Peter C; Robertson, Richard; Mayer, John E; del Nido, Pedro J; Bacha, Emile A; Forbess, Joseph M; Pigula, Frank; Roth, Stephen J; Visconti, Karen J; du Plessis, Adre J; Farrell, David M; McGrath, Ellen; Rappaport, Leonard A; Wypij, David

2008-02-01

We previously reported that postoperative hemodynamics and developmental outcomes were better among infants randomized to a higher hematocrit value during hypothermic cardiopulmonary bypass. However, worse outcomes were concentrated in patients with hematocrit values of 20% or below, and the benefits of hematocrit values higher than 25% were uncertain. We compared perioperative hemodynamics and, at 1 year, developmental outcome and brain magnetic resonance imaging in a single-center, randomized trial of hemodilution to a hematocrit value of 25% versus 35% during hypothermic radiopulmonary bypass for reparative heart surgery in infants undergoing 2-ventricle repairs without aortic arch obstruction. Among 124 subjects, 56 were assigned to the lower-hematocrit strategy (24.8% +/- 3.1%, mean +/- SD) and 68 to the higher-hematocrit strategy (32.6% +/- 3.5%). Infants randomized to the 25% strategy, compared with the 35% strategy, had a more positive intraoperative fluid balance (P = .007) and lower regional cerebral oxygen saturation at 10 minutes after cooling (P = .04) and onset of low flow (P = .03). Infants with dextro-transposition of the great arteries in the 25% group had significantly longer hospital stay. Other postoperative outcomes, blood product usage, and adverse events were similar in the treatment groups. At age 1 year (n = 106), the treatment groups had similar scores on the Psychomotor and Mental Development Indexes of the Bayley Scales; both groups scored significantly worse than population norms. Hemodilution to hematocrit levels of 35% compared with those of 25% had no major benefits or risks overall among infants undergoing 2-ventricle repair. Developmental outcomes at age 1 year in both randomized groups were below those in the normative population.

Solemnity: A Clinical Risk Index for Iron Deficient Infants.

ERIC Educational Resources Information Center

Honig, Alice Sterling; Oski, Frank A.

1984-01-01

Studies four groups of infants with iron deficiency but without anemia in an attempt to discover behavioral signs that can be used to index high-risk probability for iron deficiency. Solemnity in well-attached infants is suggested as a clinical sign to indicate the need for biochemical screening for iron deficiency. (AS)

A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

PubMed

Whitley, Julie Anne; Rich, Bonnie L

2008-12-01

To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

Randomized controlled trial comparing nasal intermittent positive pressure ventilation and nasal continuous positive airway pressure in premature infants after tracheal extubation.

PubMed

Komatsu, Daniela Franco Rizzo; Diniz, Edna Maria de Albuquerque; Ferraro, Alexandre Archanjo; Ceccon, Maria Esther Jurvest Rivero; Vaz, Flávio Adolfo Costa

2016-09-01

To analyze the frequency of extubation failure in premature infants using conventional mechanical ventilation (MV) after extubation in groups subjected to nasal intermittent positive pressure ventilation (nIPPV) and continuous positive airway pressure (nCPAP). Seventy-two premature infants with respiratory failure were studied, with a gestational age (GA) ≤ 36 weeks and birth weight (BW) > 750 g, who required tracheal intubation and mechanical ventilation. The study was controlled and randomized in order to ensure that the members of the groups used in the research were chosen at random. Randomization was performed at the time of extubation using sealed envelopes. Extubation failure was defined as the need for re-intubation and mechanical ventilation during the first 72 hours after extubation. Among the 36 premature infants randomized to nIPPV, six (16.6%) presented extubation failure in comparison to 11 (30.5%) of the 36 premature infants randomized to nCPAP. There was no statistical difference between the two study groups regarding BW, GA, classification of the premature infant, and MV time. The main cause of extubation failure was the occurrence of apnea. Gastrointestinal and neurological complications did not occur in the premature infants participating in the study. We found that, despite the extubation failure of the group of premature infants submitted to nIPPV being numerically smaller than in premature infants submitted to nCPAP, there was no statistically significant difference between the two modes of ventilatory support after extubation.

[Clinical Responses To Infants and Families.

ERIC Educational Resources Information Center

Fenichel, Emily, Ed.

1995-01-01

This journal issue focuses on family service clinical responses to infants and families. In "The Therapeutic Relationship as Human Connectedness," Jeree H. Pawl stresses the importance of caregivers creating in children the sense and experience of human connectedness that arises from the feeling of existing in the mind of someone…

Listening to Relaxing Music Improves Physiological Responses in Premature Infants: A Randomized Controlled Trial.

PubMed

Caparros-Gonzalez, Rafael A; de la Torre-Luque, Alejandro; Diaz-Piedra, Carolina; Vico, Francisco J; Buela-Casal, Gualberto

2018-02-01

Premature infants are exposed to high levels of noise in the neonatal intensive care unit (NICU). This study evaluated the effect of a relaxing music therapy intervention composed by artificial intelligence on respiratory rate, systolic and diastolic blood pressure, and heart rate. A double-blind, randomized, controlled trial was conducted in the NICUs of 2 general public hospitals in Andalusia, Spain. Participants were 17 healthy premature infants, randomly allocated to the intervention group or the control group (silence) at a 1:1 ratio. To be included in the study, the subjects were to be 32 to 36 weeks of gestation at birth (M= 32.33; SD = 1.79) and passed a hearing screening test satisfactorily. The intervention lasted 20 minutes, 3 times a day for 3 consecutive days, while infants were in the incubator. Infants' heart rate, respiratory rate, and blood pressure were assessed before and after each intervention session. After each session, the respiratory rate decreased in the experimental group (main between-groups effect (F1,13 = 6.73, P = .022, ηpartial = 0.34). Across the sessions, the heart rate increased in the control group (main between-groups effect, F1,11 = 5.09, P = .045, ηpartial = 0.32). Future studies can use this music intervention to assess its potential effects in premature infants. Nurses can apply the relaxing music intervention presented in this study to ameliorate the impact of the stressful environment on premature infants.

Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants.

PubMed

Cristofalo, Elizabeth A; Schanler, Richard J; Blanco, Cynthia L; Sullivan, Sandra; Trawoeger, Rudolf; Kiechl-Kohlendorfer, Ursula; Dudell, Golde; Rechtman, David J; Lee, Martin L; Lucas, Alan; Abrams, Steven

2013-12-01

To compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human milk. Multicenter randomized controlled trial. The authors studied extremely preterm infants whose mothers did not provide their milk. Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM. The major outcome was duration of parenteral nutrition. Secondary outcomes were growth, respiratory support, and necrotizing enterocolitis (NEC). Birth weight (983 vs 996 g) and gestational age (27.5 vs 27.7 wk), in BOV and HUM, respectively, were similar. There was a significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM, respectively (P = .04). The incidence of NEC in BOV was 21% (5 cases) vs 3% in HUM (1 case), P = .08; surgical NEC was significantly higher in BOV (4 cases) than HUM (0 cases), P = .04. In extremely preterm infants given exclusive diets of preterm formula vs human milk, there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula. This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit. Copyright © 2013 Mosby, Inc. All rights reserved.

Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial.

PubMed

Imhoff-Kunsch, Beth; Stein, Aryeh D; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle; Ramakrishnan, Usha

2011-09-01

Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58-1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and "other illness," respectively, but 74% longer duration of vomiting (all P < .05). DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.

Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial

PubMed Central

Imhoff-Kunsch, Beth; Stein, Aryeh D.; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle

2011-01-01

OBJECTIVE: Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. METHODS: In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. RESULTS: Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58–1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and “other illness,” respectively, but 74% longer duration of vomiting (all P < .05). CONCLUSIONS: DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months. PMID:21807696

Effect of Breast-Feeding and Maternal Holding in Relieving Painful Responses in Full-Term Neonates: A Randomized Clinical Trial.

PubMed

Obeidat, Hala M; Shuriquie, Mona A

2015-01-01

This randomized clinical trial was conducted to determine the efficacy of breast-feeding with maternal holding as compared with maternal holding without breast-feeding in relieving painful responses during heel lance blood drawing in full-term neonates. A convenience sample of 128 full-term newborn infants, in their fourth to sixth days of life, undergoing heel lance blood drawing for screening of hypothyroidism were included in the study. The neonates were randomly assigned into 2 equivalent groups. During heel lance blood drawing for infants, they either breast-fed with maternal holding (group I) or were held in their mother's lap without breast-feeding (group II). The painful responses were assessed simultaneously by 2 neonatal nurses blinded to the purpose of the study. Outcome measures for painful responses of the full-term neonates were evaluated with the Premature Infant Pain Profile scale. Independent t test showed significant differences in Premature Infant Pain Profile scale scores among the 2 groups (t = -8.447, P = .000). Pain scores were significantly lower among infants who were breast-fed in addition to maternal holding. Evidence from this study indicates that the combination of breast-feeding with maternal holding reduces painful responses of full-term infants during heel lance blood drawing.

Competing infant feeding information in mothers' networks: advice that supports v. undermines clinical recommendations.

PubMed

Ashida, Sato; Lynn, Freda B; Williams, Natalie A; Schafer, Ellen J

2016-05-01

To identify the social contextual factors, specifically the presence of information that supports v. undermines clinical recommendations, associated with infant feeding behaviours among mothers in low-income areas. Cross-sectional survey evaluating social support networks and social relationships involved in providing care to the infant along with feeding beliefs and practices. Out-patient paediatric and government-funded (Women, Infants, and Children) clinics in an urban, low-income area of the south-eastern USA. Eighty-one low-income mothers of infants between 0 and 12 months old. Most mothers reported receiving both supportive and undermining advice. The presence of breast-feeding advice that supports clinical recommendations was associated with two infant feeding practices that are considered beneficial to infant health: ever breast-feeding (OR=6·7; 95% CI 1·2, 38·1) and not adding cereal in the infant's bottle (OR=15·9; 95% CI 1·1, 227·4). Advice that undermines clinical recommendations to breast-feed and advice about solid foods were not associated with these behaviours. Efforts to facilitate optimal infant feeding practices may focus on increasing information supportive of clinical recommendations while concentrating less on reducing the presence of undermining information within mothers' networks. Cultural norms around breast-feeding may be stronger than the cultural norms around the introduction of solid foods in mothers' social environments; thus, additional efforts to increase information regarding introduction of solid foods earlier in mothers' infant care career may be beneficial.

Messaging Affects the Behavior of African American Parents with Regards to Soft Bedding in the Infant Sleep Environment: A Randomized Controlled Trial.

PubMed

Mathews, Anita; Joyner, Brandi L; Oden, Rosalind P; He, Jianping; McCarter, Robert; Moon, Rachel Y

2016-08-01

To evaluate the impact of specific health messages on the decisions of African American parents regarding soft bedding use, specifically related to the high degree of self-efficacy that African American parents have with regards to preventing infant suffocation vs low self-efficacy with regards to sudden infant death syndrome (SIDS) risk reduction. We conducted a randomized, controlled clinical trial of African American mothers of infants. The control group received standard messaging emphasizing safe sleep practices recommended by the American Academy of Pediatrics for the purposes of SIDS risk reduction. The intervention group received enhanced messaging emphasizing safe sleep practices for both SIDS risk reduction and suffocation prevention. Participants completed interviews at 2-3 weeks, 2-3 months, and 5-6 months after the infant's birth. Of 1194 mothers enrolled, 637 completed all interviews. The use of soft bedding both in the past week and last night declined with age (P < .001). Infants in the enhanced group had a lower rate of use of soft bedding in the past week (P = .006) and last night (P = .013). Mothers who received the enhanced message were more likely to state that they avoided soft bedding to protect their infant from suffocation. African American mothers who receive an enhanced message about SIDS risk reduction and suffocation prevention are less likely to use soft bedding in their infant's sleep environment. ClinicalTrials.gov: NCT01361880. Copyright © 2016 Elsevier Inc. All rights reserved.

Respiratory viral infections in infants with clinically suspected pertussis.

PubMed

Ferronato, Angela E; Gilio, Alfredo E; Vieira, Sandra E

2013-01-01

to evaluate the frequency of respiratory viral infections in hospitalized infants with clinical suspicion of pertussis, and to analyze their characteristics at hospital admission and clinical outcomes. a historical cohort study was performed in a reference service for pertussis, in which the research of respiratory viruses was also a routine for infants hospitalized with respiratory problems. All infants reported as suspected cases of pertussis were included. Tests for Bordetella pertussis (BP) (polymerase chain reaction/culture) and for respiratory viruses (RVs) (immunofluorescence) were performed. Patients who received macrolides before hospitalization were excluded. Clinical data were obtained from medical records. Among the 67 patients studied, BP tests were positive in 44%, and 26% were positive for RV. There was no etiological identification in 35%, and RV combined with BP was identified in 5%. All patients had similar demographic characteristics. Cough followed by inspiratory stridor or cyanosis was a strong predictor of pertussis, as well as prominent leukocytosis and lymphocytosis. Rhinorrhea and dyspnea were more frequent in viral infections. Macrolides were discontinued in 40% of patients who tested positive for RV and negative for BP. the results suggest that viral infection can be present in hospitalized infants with clinical suspicion of pertussis, and etiological tests may enable a reduction in the use of macrolides in some cases. However, the etiological diagnosis of respiratory virus infection, by itself, does not exclude the possibility of infection with BP. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Assessing a change mechanism in a randomized home-visiting trial: Reducing disrupted maternal communication decreases infant disorganization.

PubMed

Tereno, Susana; Madigan, Sheri; Lyons-Ruth, Karlen; Plamondon, Andre; Atkinson, Leslie; Guedeney, Nicole; Greacen, Tim; Dugravier, Romain; Saias, Thomas; Guedeney, Antoine

2017-05-01

Although randomized interventions trials have been shown to reduce the incidence of disorganized attachment, no studies to date have identified the mechanisms of change responsible for such reductions. Maternal sensitivity has been assessed in various studies and shown to change with intervention, but in the only study to formally assess mediation, changes in maternal sensitivity did not mediate changes in infant security of attachment (Cicchetti, Rogosch, & Toth, 2006). Primary aims of the current randomized controlled intervention trial in a high-risk population were to fill gaps in the literature by assessing whether the intervention (a) reduced disorganization, (b) reduced disrupted maternal communication, and (c) whether reductions in disrupted maternal communication mediated changes in infant disorganization. The results indicated that, compared to controls (n = 52), both infant disorganization and disrupted maternal communication were significantly reduced in the intervention group (n = 65) that received regular home-visiting during pregnancy and the first year of life. Furthermore, reductions in disrupted maternal communication partially accounted for the observed reductions in infant disorganization compared to randomized controls. The results are discussed in relation to the societal cost effectiveness of early attachment-informed interventions for mothers and infants, as well as the importance of formally assessing underlying mechanisms of change in order to improve and appropriately target preventive interventions.

Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial.

PubMed

Weber, Martina; Grote, Veit; Closa-Monasterolo, Ricardo; Escribano, Joaquín; Langhendries, Jean-Paul; Dain, Elena; Giovannini, Marcello; Verduci, Elvira; Gruszfeld, Dariusz; Socha, Piotr; Koletzko, Berthold

2014-05-01

Early nutrition is recognized as a target for the effective prevention of childhood obesity. Protein intake was associated with more rapid weight gain during infancy-a known risk factor for later obesity. We tested whether the reduction of protein in infant formula reduces body mass index (BMI; in kg/m(2)) and the prevalence of obesity at 6 y of age. The Childhood Obesity Project was conducted as a European multicenter, double-blind, randomized clinical trial that enrolled healthy infants born between October 2002 and July 2004. Formula-fed infants (n = 1090) were randomly assigned to receive higher protein (HP)- or lower protein (LP)-content formula (within recommended amounts) in the first year of life; breastfed infants (n = 588) were enrolled as an observational reference group. We measured the weight and height of 448 (41%) formula-fed children at 6 y of age. BMI was the primary outcome. HP children had a significantly higher BMI (by 0.51; 95% CI: 0.13, 0.90; P = 0.009) at 6 y of age. The risk of becoming obese in the HP group was 2.43 (95% CI: 1.12, 5.27; P = 0.024) times that in the LP group. There was a tendency for a higher weight in HP children (0.67 kg; 95% CI: -0.04, 1.39 kg; P = 0.064) but no difference in height between the intervention groups. Anthropometric measurements were similar in the LP and breastfed groups. Infant formula with a lower protein content reduces BMI and obesity risk at school age. Avoidance of infant foods that provide excessive protein intakes could contribute to a reduction in childhood obesity. This trial was registered at clinicaltrials.gov as NCT00338689.

Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial.

PubMed

Nagai, S; Andrianarimanana, D; Rabesandratana, N; Yonemoto, N; Nakayama, T; Mori, R

2010-06-01

The aim of this study was to examine the effectiveness of earlier continuous Kangaroo Mother Care (KMC) for relatively stable low-birth-weight (LBW) infants in a resource-limited country. A randomized controlled trial was performed in LBW infants at a referral hospital in Madagascar. Earlier continuous KMC (intervention) was begun as soon as possible, within 24 h postbirth, and later continuous KMC (control: conventional care) was begun after complete stabilization (generally after 24 h postbirth). Main outcome measure was mortality during the first 28 days postbirth. This trial was registered with ClinicalTrials.gov, NCT00531492. A total of 73 infants (intervention 37, control 36) were included. Earlier continuous KMC had higher but no statistically different mortality in the first 28 days postbirth (1 vs. 2; risk ratio, 1.95; 95% CIs, 0.18-20.53; p = 1.00). There were no differences in incidence of morbidities. Body weight loss from birth to 24 h postbirth was significantly less in earlier KMC infants compared with later KMC infants. (-34.81 g vs. -73.97 g; mean difference, 39.16 g; 95% CIs, 10.30-68.03; p = 0.01; adjusted p = 0.02). Adverse events and duration of hospitalization were not different between the two groups. Further evaluations of earlier continuous KMC including measurement of KMC dose, are needed in resource-limited countries.

[Clinical analysis of three cases with infant botulism and review of literature].

PubMed

Zhang, Jie; Xu, Wenrui; Zhao, Manman; Wu, Ye; Zhang, Xin; Zhang, Chunyu; Wang, Ying; Liu, Xueqin; Lu, Shan; Xu, Xuefang

2016-03-01

To analyze the clinical characteristics and diagnosis of three cases with infant botulism. Clinical data of three clinically diagnosed cases with infant botulism in May 2015 in Peking University First Hospital were retrospectively analyzed. Literature search at databases of PubMed, Wanfang, China National Knowledge Infrastructure and VIP with the key words"infant AND botulism". The date of literature retrieval was from the database founding to November 2015. The characteristics of infant botulism were summarized through review of literature. Three patients were infants of 4-8 months of age, and all had acute onsets of anorexia and poor response. All of them had normal psychomotor development previously, and without clear history of exposure to poisons. The main findings on physical examination were reduced muscle strength and hypotonia, dullness or disappeared pupillary light reflex, reduced facial expression, weak crying and dysphagia. Unexpectedly their states of consciousness were relatively normal. Finally, through identification and PCR genotyping of bacteria in stool, 2 cases were confirmed as Clostridium (C.) botulinum type B infection. Totally 446 reports were retrieved from foreign language literature and 52 reports from Chinese literature. More than 3,000 cases of infant botulism cases were reported in the world. Rare cases were reported in China and only 1 case was reported in 2000. Most cases of infant botulism had no clear exposure history. The main clinical manifestations are hypotonia, cranial nerve paralysis, flaccid paralysis, but different patients may have different presentations. Detection of C. Botulinum and its toxin in stool can help to confirm the diagnosis. Infant botulism is relatively rare in China, which may be related to the insufficient understanding and inspection level of the disease. It might be underestimated in China.

Maternal dietary counseling reduces consumption of energy-dense foods among infants: a randomized controlled trial.

PubMed

Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J

2012-01-01

To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. A randomized controlled trial. São Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home visits, or control (n = 234) groups. Child consumption of sugar-dense (SD) and lipid-dense (LD) foods at 12 to 16 months. The effect of the intervention was expressed by relative risks and 95% confidence intervals. Poisson regression analysis was used to determine the association between exclusive breastfeeding and the energy-dense foods intake. A smaller proportion of infants from the intervention group consumed candy, soft drinks, honey, cookies, chocolate, and salty snacks. In the intervention group, there was a reduction of 40% and 50% in the proportion of infants who consumed LD and SD foods, respectively. Being breastfed up to 6 months reduced the risk for consumption of LD and SD foods by 58% and 67%, respectively. Dietary counseling to mothers may be effective in reducing the consumption of energy-dense foods among infants, and it is helpful in improving early dietary habits. Copyright © 2012 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Effects of fructo-oligosaccharide-supplemented infant cereal: a double-blind, randomized trial.

PubMed

Moore, Nancy; Chao, Cewin; Yang, Li-Ping; Storm, Heidi; Oliva-Hemker, Maria; Saavedra, Jose M

2003-09-01

Fructo-oligosaccharides (FOS) may have potential benefits, since they exhibit many soluble dietary fibre-like properties. Foods currently available for weaning infants are generally low in fibre content and lack these potential benefits. Data documenting tolerance of FOS in weaning foods are greatly lacking. Our present objective was to evaluate the tolerance and gastrointestinal effects of FOS-supplemented infant cereal used as a daily addition to the diet of healthy infants. Healthy infants were randomly assigned to receive either 0.75 g FOS per serving of cereal or placebo for 28 d. The primary outcome of interest was gastrointestinal tolerance, which was assessed by daily parental reporting of functional variables for 28 d, including stool patterns and signs and symptoms of gastrointestinal tolerance. Secondary outcomes were also measured including: cereal intake (g cereal and g FOS/d), stool pH, changes in anthropometric measurements and adverse events. The study population included a total of fifty-six infants, age range 16.2-46.2 weeks with a mean age of 32.5 (sd 8.9) weeks; twenty-nine infants were randomized to the control group (age 31.8 (sd 9.0) weeks) and twenty-seven to the FOS-supplemented group (34.7 (sd 8.9) weeks). Average daily total intake per infant and average intake per serving were similar in both groups. Average FOS consumption was 0.74 (sd 0.39) g/d and as high as 3.00 g/d. Stool consistency was less likely to be described as 'hard', and more likely to be described as 'soft' or 'loose', in the FOS v. control group. The mean number of stools per infant was 1.99 (sd 0.62) per d in the FOS-supplemented group compared with 1.58 (sd 0.66) in the control group (P=0.02). There were no differences between the groups in reporting for crying, spitting-up or colic. No differences were found for stool pH. FOS-supplements added to cereal were well tolerated in doses of up to 3.00 g/d. FOS consumption led to more regular and softer stools, without

Pediatric Tuina for promoting growth and development of preterm infants: A protocol for the systematic review of randomized controlled trail.

PubMed

Zhang, Xinghe; Guo, Taipin; Zhu, Bowen; Gao, Qing; Wang, Hourong; Tai, Xiantao; Jing, Fujie

2018-05-01

Preterm infants are babies born alive before 37 weeks. Many survived infants concomitant with defects of growth and development, a lifetime of disability usually as following when insufficient intervention. In early intervention of preterm infants, pediatric Tuina shows good effect in many Chinese and some English clinical trials. This systematic review is aimed to evaluate the efficacy and safety of pediatric Tuina for promoting growth and development of preterm infants. The electronic databases of Cochrane Library, MEDLINE, EBASE, Web of Science, Springer, World Health Organization International Clinical Trials Registry Platform, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wan-fang database, Chinese Scientific Journal Database, and other databases will be searched from establishment to April 1, 2018. All published randomized controlled trials (RCTs) about this topic will be included. Two independent researchers will operate article retrieval, screening, quality evaluation, and data analyses by Review Manager (V.5.3.5). Meta-analyses, subgroup analysis, and/or descriptive analysis will be performed based on included data conditions. High-quality synthesis and/or descriptive analysis of current evidence will be provided from weight increase, motor development, neuropsychological development, length of stay, days of weight recovery to birthweight, days on supplemental oxygen, daily sleep duration, and side effects. This study will provide the evidence of whether pediatric Tuina is an effective early intervention for preterm infants. There is no requirement of ethical approval and informed consent, and it will be in print or published by electronic copies. This systematic review protocol has been registered in the PROSPERO network (No. CRD42018090563).

[Pharmacokinetic and clinical studies of ceftizoxime in newborn infants].

PubMed

Sato, H; Nakazawa, S; Narita, A; Nakazawa, S; Matsumoto, K; Suzuki, H; Nakanishi, Y; Chikaoka, H; Kamigaki, M; Niino, K

1988-08-01

Pharmacokinetic and clinical studies of ceftizoxime (CZX) were performed in infants given intravenously. The obtained results are summarized as follows. 1. Serum concentrations of CZX in 2 and 3 day-old mature infants given 20 mg/kg by one shot intravenous injection peaked at 49.0 and 57.9 micrograms/ml in 1 hour and decreased to 14.4 and 24.9 micrograms/ml in 8 hours after dosing, respectively. Half-lives were 3.9 and 5.6 hours, respectively. In 5 day-old or older mature infants, peak serum levels ranged from 20.9 to 38.0 micrograms/ml at 1 hour after the injection. Levels of CZX at 8 hours after injection were 1.31 to 7.32 micrograms/ml. Half-lives were 1.6-3.0 hours in all the infants except one. 2. In a 3 day-old premature infant given the same dose by a bolus intravenous injection, the serum level peaked at 45.7 micrograms/ml in 1 hour after the injection. The level at 8 hours after injection was 15.7 micrograms/ml. The half-life was 4.2 hours. In 5-15 day-old premature infants, half-lives were 2.3-3.1 hours in all the infants except one. 3. Serum concentrations of CZX in 1 and 2 day-old infants given 20 mg/kg by intravenous drip infusion peaked at 49.4 to 115.0 micrograms/ml in 1 hour after dosing. Half-lives were rather long, 4.0 and 5.1 hours, in the 2 infants. 4. Peak serum levels and half-lives tended to be lower and shorter in 5 day-old or older ones than in the 3 day-old or younger infants. 5. No changes in the serum concentration were observed even after dosing with 20 mg/kg of continuous one shot intravenous injection. 6. Urinary recovery rates during the first 8 hours (one is 6 hours, two is 9 hours) after 20 mg/kg intravenous bolus injection of CZX tended to be lower in 3 day-old or younger infants than in 5 day-old or older infants. 7. Eleven infants with various bacterial infections were given CZX by intravenous bolus injection or drip infusion. Dosage of CZX used in the present study were 36-148 mg/kg/day in 2-3 divided doses. Duration of

A randomized case-controlled study of recombinant human granulocyte colony stimulating factor for the treatment of sepsis in preterm neutropenic infants.

PubMed

Aktaş, Doğukan; Demirel, Bilge; Gürsoy, Tuğba; Ovalı, Fahri

2015-06-01

To investigate the efficacy and safety of recombinant human granulocyte colony-stimulating factor, recombinant human granulocyte-macrophage colony-stimulating factor (rhG-CSF) to treat sepsis in neutropenic preterm infants. Fifty-six neutropenic preterm infants with suspected or culture-proven sepsis hospitalized in Zeynep Kamil Maternity and Children's Educational and Training Hospital, Kozyatağı/Istanbul, Turkey between January 2008 and January 2010 were enrolled. Patients were randomized either to receive rhG-CSF plus empirical antibiotics (Group I) or empirical antibiotics alone (Group II). Clinical features were recorded. Daily complete blood count was performed until neutropenia subsided. Data were analyzed using SPSS version 11.5. Thirty-three infants received rhG-CSF plus antibiotic treatment and 23 infants received antibiotic treatment. No drug-related adverse event was recorded. Absolute neutrophil count values were significantly higher on the 2(nd) study day and 3(rd) study day in Group I. Short-term mortality did not differ between the groups. Treatment with rhG-CSF resulted in a more rapid recovery of ANC in neutropenic preterm infants. However, no reduction in short-term mortality was documented. Copyright © 2014. Published by Elsevier B.V.

Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial.

PubMed

Olafsen, Kåre S; Rønning, John A; Handegård, Bjørn Helge; Ulvund, Stein Erik; Dahl, Lauritz Bredrup; Kaaresen, Per Ivar

2012-02-01

Temperamental regulatory competence and social communication in term and preterm infants at 12 months corrected age was studied in a randomized controlled intervention trial aimed at enhancing maternal sensitive responsiveness. Surviving infants <2000 g from a geographically defined area were randomized to an intervention (71) or a control group (69), and compared with term infants (74). The intervention was a modified version of the "Mother-Infant Transaction Program". Regulatory competence was measured with the Infant Behavior Questionnaire, and social communication with the Early Social Communication Scales. Preterm intervention infants with low regulatory competence had higher responding to joint attention than preterm control infants. A sensitizing intervention may moderate the association between temperament and social communication, and thus allow an alternative functional outlet for preterm infants low in regulatory competence. The finding may have implications for conceptualizations of the role of early sensitizing interventions in promoting important developmental outcomes for premature infants. Copyright © 2011 Elsevier Inc. All rights reserved.

Adding "Circle of Security - Parenting" to treatment as usual in three Swedish infant mental health clinics. Effects on parents' internal representations and quality of parent-infant interaction.

PubMed

Risholm Mothander, Pia; Furmark, Catarina; Neander, Kerstin

2018-06-01

This study presents effects of adding Circle of Security-Parenting (COS-P) to an already established comprehensive therapeutic model for early parent-child intervention in three Swedish infant mental health (IMH) clinics. Parents' internal representations and quality of parent-infant interaction were studied in a clinical sample comprised of 52 parent-infant dyads randomly allocated to two comparable groups. One group consisted of 28 dyads receiving treatment as usual (TAU) supplemented with COS-P in a small group format, and another group of 24 dyads receiving TAU only. Assessments were made at baseline (T1), 6 months after inclusion (T2) and 12 months after inclusion (T3). Changes over time were explored in 42 dyads. In the COS-P group, the proportion of balanced representations, as assessed with Working Model of the Child Interview (WMCI), significantly increased between T1 and T3. Further, the proportion of emotionally available interactions, as assessed with Emotional Availability scales (EA), significantly increased over time in the COS-P group. Improvements in the TAU-group were close to significant. Limitations of the study are mainly related to the small sample size. Strength is the real world character of the study, where COS-P was implemented in a clinical context not otherwise adapted to research. We conclude by discussing the value of supplementing TAU with COS-P in IMH treatment. © 2017 The Authors. Scandinavian Journal of Psychology published by Scandinavian Psychological Associations and John Wiley & Sons Ltd.

Urinary Excretion of Phenolic Acids by Infants and Children: A Randomised Double-Blind Clinical Assay

PubMed Central

Uberos, J.; Fernández-Puentes, V.; Molina-Oya, M.; Rodríguez-Belmonte, R.; Ruíz-López, A.; Tortosa-Pinto, P.; Molina-Carballo, A.; Muñoz-Hoyos, A.

2012-01-01

Objectives: The present study, which is part of the ISRCTN16968287 clinical assay, is aimed at determining the effects of cranberry syrup or trimethoprim treatment for UTI. Methods: This Phase III randomised clinical trial was conducted at the San Cecilio Clinical Hospital (Granada, Spain) with a study population of 192 patients, aged between 1 month and 13 years. Criteria for inclusion were a background of recurrent UTI, associated or otherwise with vesico-ureteral reflux of any degree, or renal pelvic dilatation associated with urinary infection. Each child was randomly given 0.2 mL/Kg/day of either cranberry syrup or trimethoprim (8 mg/mL). The primary and secondary objectives, respectively, were to determine the risk of UTI and the levels of phenolic acids in urine associated with each intervention. Results: With respect to UTI, the cranberry treatment was non-inferior to trimethoprim. Increased urinary excretion of ferulic acid was associated with a greater risk of UTI developing in infants aged under 1 year (RR 1.06; CI 95% 1.024–1.1; P = 0.001). Conclusions: The results obtained show the excretion of ferulic acid is higher in infants aged under 1 year, giving rise to an increased risk of UTI, for both treatment options. PMID:23641168

Clinical and demographic factors associated with urinary tract infection in young febrile infants.

PubMed

Zorc, Joseph J; Levine, Deborah A; Platt, Shari L; Dayan, Peter S; Macias, Charles G; Krief, William; Schor, Jeffrey; Bank, David; Shaw, Kathy N; Kuppermann, Nathan

2005-09-01

Previous research has identified clinical predictors for urinary tract infection (UTI) to guide urine screening in febrile children <24 months of age. These studies have been limited to single centers, and few have focused on young infants who may be most at risk for complications if a UTI is missed. The objective of this study was to identify clinical and demographic factors associated with UTI in febrile infants who are < or =60 days of age using a prospective multicenter cohort. We conducted a multicenter, prospective, cross-sectional study during consecutive bronchiolitis seasons. All febrile (> or =38 degrees C) infants who were < or =60 days of age and seen at any of 8 pediatric emergency departments from October through March 1999-2001 were eligible. Clinical appearance was evaluated using the Yale Observation Scale. UTI was defined as growth of a known bacterial pathogen from a catheterized specimen at a level of (1) > or =50000 cfu/mL or (2) > or =10000 cfu/mL in association with a positive dipstick test or urinalysis. We used bivariate tests and multiple logistic regression to identify demographic and clinical factors that were associated with the likelihood of UTI. A total of 1025 (67%) of 1513 eligible patients were enrolled; 9.0% of enrolled infants received a diagnosis of UTI. Uncircumcised male infants had a higher rate of UTI (21.3%) compared with female (5.0%) and circumcised male (2.3%) infants. Infants with maximum recorded temperature of > or =39 degrees C had a higher rate of UTI (16.3%) than other infants (7.2%). After multivariable adjustment, UTI was associated with being uncircumcised (odds ratio: 10.4; bias-corrected 95% confidence interval: 4.7-31.4) and maximum temperature (odds ratio: 2.4 per degrees C; 95% confidence interval: 1.5-3.6). Factors that were reported previously to be associated with risk for UTI in infants and toddlers, such as white race and ill appearance, were not significantly associated with risk for UTI in this

Severe congenital toxoplasmosis in the United States: clinical and serologic findings in untreated infants.

PubMed

Olariu, Tudor Rares; Remington, Jack S; McLeod, Rima; Alam, Ambereen; Montoya, Jose G

2011-12-01

Congenital toxoplasmosis can cause significant neurologic manifestations and other untoward sequelae. The Palo Alto Medical Foundation Toxoplasma Serology Laboratory database was searched for data on infants 0 to 180 days old, in whom congenital toxoplasmosis had been confirmed and who had been tested for Toxoplasma gondii-specific immunoglobulin G (IgG), IgM, and IgA antibodies, between 1991 and 2005. Their clinical findings were confirmed at the National Collaborative Chicago-based Congenital Toxoplasmosis Study center. We reviewed available clinical data and laboratory profiles of 164 infants with congenital toxoplasmosis whose mothers had not been treated for the parasite during gestation. One or more severe clinical manifestations of congenital toxoplasmosis were reported in 84% of the infants and included eye disease (92.2%), brain calcifications (79.6%), and hydrocephalus (67.7%). In 61.6% of the infants, eye disease, brain calcifications, and hydrocephalus were present concurrently. T. gondii-specific IgM, IgA, and IgE antibodies were demonstrable in 86.6%, 77.4%, and 40.2% of the infants, respectively. Testing for IgM and IgA antibodies increased the sensitivity of making the diagnosis of congenital toxoplasmosis to 93% compared with testing for IgM or IgA individually. IgM and IgA antibodies were still present in 43.9% of infants diagnosed between 1 and 6 months of life. Our study reveals that severe clinical signs of congenital toxoplasmosis including hydrocephalus, eye disease, or intracranial calcifications occurred in 85% infants whose sera were referred to our reference Toxoplasma Serology Laboratory during a period of 15 years. Laboratory tests, including serologic and polymerase chain reaction tests, were critical for diagnosis in the infants. Our results contrast remarkably with those of European investigators who rarely observe severe clinical signs in infants with congenital toxoplasmosis.

Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study.

PubMed

Torsvik, Ingrid; Ueland, Per Magne; Markestad, Trond; Bjørke-Monsen, Anne-Lise

2013-11-01

During infancy, minor developmental delays and gastrointestinal complaints are common, as is a biochemical profile indicative of impaired cobalamin status. We investigated whether cobalamin supplementation can improve development or symptoms in infants with biochemical signs of impaired cobalamin function and developmental delay or feeding difficulties. Infants <8 mo of age (n = 105) who were referred for feeding difficulties, subtle neurologic symptoms, or delayed psychomotor development were assessed for cobalamin status [by the measurement of serum cobalamin, plasma total homocysteine (tHcy), and plasma methylmalonic acid (MMA)]. Infants with biochemical signs of impaired cobalamin function, defined as a plasma tHcy concentration ≥6.5 μmol/L (n = 79), were enrolled in a double-blind, randomized controlled trial to receive 400 μg hydroxycobalamin intramuscularly (n = 42) or a sham injection (n = 37). Motor function [Alberta Infants Motor Scale (AIMS)] and clinical symptoms (parental questionnaire) were recorded at entry and after 1 mo. During follow-up, cobalamin supplementation changed all markers of impaired cobalamin status (ie, plasma tHcy decreased by 54%, and MMA decreased by 84%), whereas no significant changes were seen in the placebo group (P < 0.001). The median (IQR) increase in the AIMS score was higher in the cobalamin group than in the placebo group [7.0 (5.0, 9.0) compared with 4.5 (3.3, 6.0); P = 0.003], and a higher proportion showed improvements in regurgitations (69% compared with 29%, respectively; P = 0.003). In infants with biochemical signs of impaired cobalamin function, 1 intramuscular injection of cobalamin resulted in biochemical evidence of cobalamin repletion and improvement in motor function and regurgitations, which suggest that an adequate cobalamin status is important for a rapidly developing nervous system. This trial was registered at clinicaltrials.gov as NCT00710359 and NCT00710138.

Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a randomized controlled trial.

PubMed

Boyle, R J; Tang, M L-K; Chiang, W C; Chua, M C; Ismail, I; Nauta, A; Hourihane, J O B; Smith, P; Gold, M; Ziegler, J; Peake, J; Quinn, P; Rao, R; Brown, N; Rijnierse, A; Garssen, J; Warner, J O

2016-05-01

Prevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes. To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597]. We conducted a parallel-group, multicentre, randomized double-blind controlled trial of pHF-OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0-4 weeks (375 pHF-OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events. Eczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF-OS at 0-4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF-OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF-OS did not change most immune markers including total/specific IgE; however, pHF-OS reduced cow's milk-specific IgG1 (P < 0.0001) and increased regulatory T-cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events. pHF-OS does not prevent eczema in the first year in high-risk infants. The immunological changes found require confirmation in a separate cohort. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy.

PubMed

Akula, Vishnu Priya; Joe, Priscilla; Thusu, Kajori; Davis, Alexis S; Tamaresis, John S; Kim, Sunhwa; Shimotake, Thomas K; Butler, Stephen; Honold, Jose; Kuzniewicz, Michael; DeSandre, Glenn; Bennett, Mihoko; Gould, Jeffrey; Wallenstein, Matthew B; Van Meurs, Krisa

2015-04-01

To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice. We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California. Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling. The primary outcome was the percentage of temperatures in target range (33°-34°C) during transport. Secondary outcomes included percentage of newborns reaching target temperature any time during transport, time to target temperature, and percentage of newborns in target range 1 hour after cooling initiation. One hundred newborns were enrolled: 49 to control arm and 51 to device arm. Baseline demographics did not differ with the exception of cord pH. For each subject, the percentage of temperatures in the target range was calculated. Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants (median 73% [IQR 17-88] vs 0% [IQR 0-52], P < .001). More subjects reached target temperature during transport using the servo-regulated device (80% vs 49%, P <.001), and in a shorter time period (44 ± 31 minutes vs 63 ± 37 minutes, P = .04). Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants (71% vs 20%, P < .001). Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of home visit training program on growth and development of preterm infants: a double blind randomized controlled trial.

PubMed

Edraki, Mitra; Moravej, Hossian; Rambod, Masoume

2015-01-01

Home visit program can be effective in infants' growth and development. The present study aimed to investigate the effect of home visit program on preterm infants' growth and development within 6 months. It was a double-blind clinical trial study. The study was conducted in Hafez, Hazrat-e-Zeinab, and Namazee Hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran from 2010 to 2011. Preterm infants were divided into intervention (n=30) and control groups (n=30) through blocked randomization. The intervention group received home visit training program for 6 months, while the control group only received the hospital's routine care. Then, the infants' growth indexes, including weight, height, and head circumference, and development criteria were compared on the first day of admission in Neonatal Intensive Care Unit, and then first, second, third, and sixth months. The data were analyzed using Chi-square, independent t-test, and repeated measures ANCOVA. The mean weight of the intervention and control group infants was 7207.3±1129.74 and 6366.7±922.26 gr in the sixth month. Besides, the intervention group infants' mean weight was higher compared to the control group after six months (t=-3.05, P=0.03). Also, a significant difference was found between the two groups regarding development indexes, such as following moving objects with the head, keeping the head stable when changing the position from lying to sitting,  producing "Agha" sound, and taking objects by hand (P<0.05) during six months of age. The results showed that the home visit program was effective in preterm infants' weight gain and some development indexes at the sixth month. Considering the importance of infants' growth and development, healthcare staff is recommended to incorporate home visit training into their programs, so that steps can be taken towards improvement of preterm infants' health. IRCT2014082013690N3 

Long-term mother and child mental health effects of a population-based infant sleep intervention: cluster-randomized, controlled trial.

PubMed

Hiscock, Harriet; Bayer, Jordana K; Hampton, Anne; Ukoumunne, Obioha C; Wake, Melissa

2008-09-01

Maternal depression is an established risk for adverse child development. Two thirds of clinically significant depressive symptoms occur in mothers reporting an infant sleep problem. We aimed to determine the long-term effects of a behavioral intervention for infant sleep problems on maternal depression and parenting style, as well as on child mental health and sleep, when the children reached 2 years of age. We conducted a cluster-randomized trial in well-child centers across 6 government areas of Melbourne, Australia. Participants included 328 mothers reporting an infant sleep problem at 7 months, drawn from a population sample (N = 739) recruited at 4 months. We compared the usual well-child care (n = 154) versus a brief behavior-modification program designed to improve infant sleep (n = 174) delivered by well-child nurses at ages 8 to 10 months and measured maternal depression symptoms (Edinburgh Postnatal Depression Scale); parenting practices (Parent Behavior Checklist); child mental health (Child Behavior Checklist); and maternal report of a sleep problem (yes or no). At 2 years, mothers in the intervention group were less likely than control mothers to report clinical depression symptoms: 15.4% vs 26.4% (Edinburgh Postnatal Depression Scale community cut point) and 4.2% vs 13.2% (Edinburgh Postnatal Depression Scale clinical cut point). Neither parenting style nor child mental health differed markedly between the intervention and control groups. A total of 27.3% of children in the intervention group versus 32.6% of control children had a sleep problem. The sleep intervention in infancy resulted in sustained positive effects on maternal depression symptoms and found no evidence of longer-term adverse effects on either mothers' parenting practices or children's mental health. This intervention demonstrated the capacity of a functioning primary care system to deliver effective, universally offered secondary prevention.

Positive end-expiratory pressure during resuscitation at birth in very-low birth weight infants: A randomized-controlled pilot trial.

PubMed

Kitsommart, Ratchada; Nakornchai, Kittaya; Yangthara, Buranee; Jiraprasertwong, Ratchada; Paes, Bosco

2017-12-09

There is limited evidence of the effect of positive end-expiratory pressure (PEEP) during resuscitation soon after birth. Premature neonates may experience respiratory distress from surfactant insufficiency and providing PEEP after the very first breath, may improve outcomes following appropriate resuscitation. The objective of this study was to evaluate the short term respiratory outcomes after positive pressure ventilation (PPV) with PEEP in preterm infants at birth. A prospective randomized-controlled, pilot trial was conducted. Premature neonates ≤ 32 weeks gestational age or birth weight < 1500 g were recruited. Subjects were allocated to either PEEP of 5 cm H 2 O (PEEP-5) or no PEEP (PEEP-0) if PPV was administered. Pre-ductal, peripheral capillary oxygen saturation (SpO 2 ) and fraction of inspired oxygen concentration (FiO 2 ) were monitored at 1, 3, 5, 10, 15, and 20 min after birth. FiO 2 was adjusted to achieve targeted SpO 2 using the 2010 neonatal resuscitation protocol guidelines. 56% (14/25; PEEP-0) and 50% (13/26; PEEP-5) infants received PPV. Mean gestational age was 30 (PEEP-0) vs 31 (PEEP-5) weeks. The mean [SD] birthweight (g) of PEEP-0 was significantly lower than PEEP-5 (1050.4 [262.7] vs 1218.8 [236.8], p = 0.02). Pre-ductal SpO 2, FiO 2 delivered at each time point, and rates of pneumothorax, surfactant administration and oxygen dependency at 36 weeks postmenstrual age or death was similar. Due to the small sample size and potential bias accrued through random allocation of higher birthweight infants to the PEEP-5 group, the results did not confirm differences in outcomes between the groups, despite evidence favoring postnatal ventilation with PEEP. A further randomized, controlled clinical trial with a larger sample size is warranted to determine the utility and safety of PEEP during the resuscitation of premature infants immediately after birth. Copyright © 2017. Published by Elsevier B.V.

The interface of self psychology, infant research, and neuroscience in clinical practice.

PubMed

Rustin, Judith

2009-04-01

This article focuses on the integration of self psychology with findings from infant research and neuroscience. While Kohut's psychology of the self provides a useful theoretical model for psychoanalytic practice, aspects of infant research and neuroscience offer specificity and nuance to basic self-psychological concepts. Kohut proposed that self-psychological psychoanalysis ameliorates derailed development through patient-analyst interaction, while a listening stance of empathic immersion begins the curative process of derailed development and sets the stage for reparative psychoanalytic work. Findings from infant research delineate much more specifically the nature of attunement both in early mother-infant and analyst-patient interactions. Findings from neuroscientific research delineate how early mother-infant experiences are encoded in implicit memory and explicates the emotional substrate of affects and feelings. This emotional substrate exists at birth and provides a means of communication both in infancy and adulthood. Additionally, infant research delineates the mutuality of the interactive process. Thus, both infant research and neuroscience add subtlety and nuance to basic self-psychological concepts. This subtlety opens up new ways of understanding patients and expands the clinical repertoire. Three clinical vignettes demonstrate how this nuance and expansion of self-psychological concepts are applied in the context of an ongoing psychoanalytic treatment.

Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socioemotional outcome.

PubMed

Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J

2016-12-01

Consistent with evidence from high-income countries (HICs), we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book sharing with their infants benefitted infant language and attention (Vally, Murray, Tomlinson, & Cooper, ). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socioemotional development benefitted from book sharing. We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14-16-month-old infants were randomized to 8 weeks' training in book sharing (n = 49) or a wait-list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book sharing and toy play. Assessments were also made, at follow-up only, of infant prosocial behaviour in a 'help task', and of infant imitation of doll characters' nonsocial actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of prosocial behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also shows promise for

Nasogastric hydration versus intravenous hydration for infants with bronchiolitis: a randomised trial.

PubMed

Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Acworth, Jason; Krieser, David; Dalziel, Stuart; Davidson, Andrew; Donath, Susan; Jachno, Kim; South, Mike; Theophilos, Theane; Babl, Franz E

2013-04-01

Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants. In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640. Mean length of stay for 381 infants assigned nasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in the intravenous hydration group required only one attempt for successful

Comparison of analgesic effect of direct breastfeeding, oral 25% dextrose solution and placebo during 1st DPT vaccination in healthy term infants: a randomized, placebo controlled trial.

PubMed

Goswami, Gaurav; Upadhyay, Amit; Gupta, Navratan Kumar; Chaudhry, Rajesh; Chawla, Deepak; Sreenivas, V

2013-07-01

To compare analgesic effect of direct breast feeding, 25% dextrose solution and placebo as we give 1st intramuscular whole cell DPT injection to 6week - 3month old infants. Randomized, placebo controlled trial. Immunization clinic of Department of Pediatrics, LLRM Medical College. Infants coming for their 1st DPT vaccination were randomized in to three groups of 40 each. The primary outcome variable was the duration of cry after vaccination. Secondary outcome variables were Modified Facial Coding Score (MFCS) and latency of onset of cry. 120 babies were equally enrolled in breast feed group, 25% dextrose fed group and distilled water fed group. Median (interquartile range) of duration of cry was significantly lower in breast fed (33.5 (17-54) seconds) and 25% dextrose fed babies (47.5 (31-67.5) seconds) as compared to babies given distilled water (80.5 (33.5-119.5) seconds) (P<0.001). MFCS at 1 min and 3 min was significantly lower in direct breast fed and dextrose fed babies. Direct breastfeeding and 25% dextrose act as analgesic in young infants undergoing DPT vaccination in young infants less than 3 month of age.

Randomized controlled trial of two methods of nasal continuous positive airway pressure (N-CPAP) in preterm infants with respiratory distress syndrome: underwater bubbly CPAP vs. Medijet system device.

PubMed

Hosseini, Mohammad Bagher; Heidarzadeh, Mohammad; Balila, Masumeh; Ghojazadeh, Morteza; Janani, Raheleh; Safavi-nia, Sima; Naghavi-Behzad, Mohammad; Alikhah, Hossein

2012-01-01

There has been an increasing interest in the application of non-invasive respiratory support in preterm infants, and different types of nasal continuous positive airway pressure (N-CPAP) devices are being used in Neonatal Intensive Care Units (NICUs). The objective of the present study was to compare the duration of CPAP need and possible complications of two methods of (N-CPAP) delivery: Bubble CPAP (B-CPAP) and Medijet (MJ) system device in preterm infants with respiratory distress syndrome (RDS). This prospective randomized clinical trial was performed on 161 preterm infants (28-37 weeks of gestational age) with RDS and eligible for CPAP therapy. The infants were inborn and admitted in a level III NICU of Al-Zahra Teaching Hospital (Tabriz, Iran) from April 2010 to September 2011. All infants were randomized in the first hour of life to B-CPAP or MJ system. Short binasal prongs were used in both groups and CPAP was set at the level of 5-6 cm H2O. The primary outcome of this study was duration of CPAP need (hour). Other outcomes, such as complications of the two methods of N-CPAP, were evaluated using a checklist. Ninety infants were randomized to the MJ system, and 71 were randomized to B-CPAP. The mean gestational age and birth weight were similar in the two groups, as was the duration of CPAP need (44.3 ± 20.64 vs. 49.2 ± 21.2 hours, respectively; p=0.66). Moreover, the probability of complications, such as CPAP failure rate, pulmonary hemorrhage, pneumothorax, intraventricular hemorrhage, abdominal distention, necrotizing enterocolitis, and bronchopulmonary dysplasia, was the same between the two study groups (p>0.05). There was a trend of more hyperemia of the nose in the B-CPAP group in comparison to the MJ system group (10% versus 3.3%, respectively), but the difference was not significant (p=0.08). In conclusion, the MJ system is as effective as B-CPAP in the management of infants with RDS.

Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial.

PubMed

Cheung, D; Mian, Q; Cheung, P-Y; O'Reilly, M; Aziz, K; van Os, S; Pichler, G; Schmölzer, G M

2015-07-01

If an infant fails to initiate spontaneous breathing after birth, international guidelines recommend a positive pressure ventilation (PPV). However, PPV by face mask is frequently inadequate because of leak between the face and mask. Despite a variety of available face masks, none have been prospectively compared in a randomized fashion. We aimed to evaluate and compare leak between two commercially available round face masks (Fisher & Paykel (F&P) and Laerdal) in preterm infants <33 weeks gestational age in the delivery room. Infants born at the Royal Alexandra Hospital from April to September 2013 at <33 weeks gestational age who received mask PPV in the delivery room routinely had a flow sensor placed between the mask and T-piece resuscitator. Infants were randomly assigned to receive PPV with either a F&P or Laerdal face mask. All resuscitators were trained in the use of both face masks. We compared mask leak, airway pressures, tidal volume and ventilation rate between the two groups. Fifty-six preterm infants (n=28 in each group) were enrolled; mean±s.d. gestational age 28±3 weeks; birth weight 1210±448 g; and 30 (52%) were male. Apgar scores at 1 and 5 min were 5±3 and 7±2, respectively. Infants randomized to the F&P face mask and Laerdal face mask had similar mask leak (30 (25-38) versus 35 (24-46)%, median (interquartile range), respectively, P=0.40) and tidal volume (7.1 (4.9-8.9) versus 6.6 (5.2-8.9) ml kg(-1), P=0.69) during PPV. There were no significant differences in ventilation rate, inflation time or airway pressures between groups. The use of either face mask during PPV in the delivery room yields similar mask leak in preterm infants <33 weeks gestational age.

Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socio-emotional outcome

PubMed Central

Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J.

2017-01-01

Background Consistent with evidence from high income countries, we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book-sharing with their infants benefitted infant language and attention (Vally et al., 2015). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socio-emotional development benefitted from book-sharing. Methods We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14–16 month-old infants were randomized to 8 weeks’ training in book-sharing (n = 49) or a wait list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book-sharing and toy play. Assessments were also made, at follow-up only, of infant pro-social behaviour in a ‘help task’, and of infant imitation of doll characters’ non-social actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Results Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of pro-social behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book-sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Conclusions Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses.

PubMed

Bozkurt, Ozlem; Uras, Nurdan; Sari, Fatma Nur; Atay, Funda Yavanoglu; Sahin, Suzan; Alkan, Ayse Dogan; Canpolat, Fuat Emre; Oguz, Serife Suna

2017-09-01

Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants. To assess the effect of three different doses of vitamin D supplementation (400, 800 and 1000IU/d) in preterm infants ≤32weeks gestation on the prevalence of vitamin D deficiency and 25(OH) D levels at 36weeks postmenstrual age (PMA). Prospective randomized trial. 121 preterm infants with gestational age of 24-32weeks were randomly allocated to receive 400, 800 or 1000IU/d vitamin D. Serum concentration of 25(OH) D and the prevalence of vitamin D deficiency at 36weeks PMA. Vitamin D deficiency was defined as serum 25(OH) D concentrations <20ng/ml. Of the 121 infants 72% had deficient vitamin D levels before supplementation. The average 25(OH) vitamin D concentrations at 36weeks PMA were significantly higher in 800IU (40±21.4ng/ml) and 1000IU group (43±18.9ng/ml) when compared to 400IU group (29.4±13ng/ml). The prevalence of vitamin D deficiency (2.5 vs 22.5; RR: 0.09; CI:0.01-0.74) and insufficiency (30 vs 57.5; RR:0.32; CI:0.13-0.80) was significantly lower in 1000IU group when compared to 400IU group at 36weeks PMA. 1000IU/d of vitamin D supplementation in preterm infants ≤32weeks gestation age effectively decreases the prevalence of vitamin D deficiency and leads to higher concentrations of 25(OH) vitamin D at 36weeks PMA TRIAL REGISTRATION: Clinical Trials.gov: NCT02941185. Copyright © 2017. Published by Elsevier B.V.

Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity?

PubMed

Bührer, Christoph; Bassler, Dirk

2015-01-01

Oral propranolol has improved the treatment of infantile hemangiomas, and a pediatric oral solution of propranolol has recently been licensed in the USA and Europe. In very preterm infants, infantile hemangiomas are associated with the occurrence of retinopathy of prematurity (ROP), and both diseases share a peculiar time course, featuring a lag phase after birth followed by rapid growth and then gradual regression. To identify clinical studies evaluating the use of oral propranolol in preterm infants with ROP. Two small bicentric, pilot, randomized controlled trials found a nonsignificant reduction of ROP requiring intervention by laser treatment or bevacizumab injection of similar magnitude. Together, 6 of 35 (17%) infants who had been receiving oral propranolol underwent ROP intervention, as opposed to 14 of 36 (39%) controls (relative risk 0.42, 95% CI: 0.15-1.16). Randomized controlled trials are ongoing that investigate early preventive oral propranolol starting at 1 week of age and propranolol eye drops in preterm infants with stage 2 ROP. Further, large interventional studies are required to determine the clinical benefit-risk ratio of oral propranolol to prevent vision-threatening ROP in very preterm infants. © 2015 S. Karger AG, Basel.

A Randomized Controlled Trial of a Home-Visiting Intervention Aimed at Preventing Relationship Problems in Depressed Mothers and Their Infants

ERIC Educational Resources Information Center

van Doesum, Karin T. M.; Riksen-Walraven, J. Marianne; Hosman, Clemens M. H.; Hoefnagels, Cees

2008-01-01

This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home…

The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial.

PubMed

Koç, Tuba; Gözen, Duygu

2015-10-01

This study was a randomized controlled trial designed to evaluate the effect of foot reflexology applied on infants on acute pain that may arise after vaccine injection. The sample consisted of 1- to 12-month-old infants registered in a family health center in Istanbul, Turkey, for healthcare follow-up. A total of 60 infants who met the criteria of the sample group were included in the study; 30 infants constituted the reflexology group and the other 30 constituted the control group. Although questionnaire forms were used to determine the descriptive characteristics of infant-mother pairs, the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used to evaluate pain level. Infants in the reflexology group received reflexology treatment for an average of 20-30 minutes before vaccination, depending on the physical size of the infant's foot. Pain, heart rate, oxygen saturation levels, and crying periods of infants in the reflexology and control groups were evaluated before and after vaccination. The FLACC pain score was observed to be statistically similar between groups. After reflexology was applied to infants in the reflexology group before vaccination, it was determined that the pain score was reduced to .50 ± 1.14. In the examination performed after vaccination, FLACC pain score was found to be 5.47 ± 2.11 in the reflexology group and 9.63 ± .85 in the control group. A statistically significant difference was observed between the mean FLACC pain scores of infants in the reflexology and control groups (p = .000). The infants in the reflexology group also had lower heart rates, higher oxygen saturation, and shorter crying periods than the infants in the control group (p <.001). Reflexology before vaccine reduced the pain level experienced after vaccination. Future research needs to explore different interventional practices. © 2015 Sigma Theta Tau International.

Impact of Vitamin D Supplementation on Gross Motor Development of Healthy Term Infants: A Randomized Dose-Response Trial.

PubMed

Wicklow, Brandy; Gallo, Sina; Majnemer, Annette; Vanstone, Catherine; Comeau, Kathryn; Jones, Glenville; L'Abbe, Mary; Khamessan, Ali; Sharma, Atul; Weiler, Hope; Rodd, Celia

2016-08-01

In addition to benefits for bone health, vitamin D is implicated in muscle function in children and adults. To determine if vitamin D dosage positively correlated with gross motor development at 3 and 6 months of age. We hypothesized that higher doses would be associated with higher scores for gross motor skills. A consecutive sample of 55 healthy, term, and breastfed infants from Montreal, Canada were recruited from a randomized trial of vitamin D supplementation between 2009 and 2012. Infants were randomized to 400 International Units (IU) (n = 19), 800 IU (n = 18) or 1,200 IU (n = 18) vitamin D3/day. Motor performance at 3 and 6 months was quantified by the Alberta Infant Motor Scale (AIMS). Plasma vitamin D3 metabolites were measured by tandem mass spectrometry. AIMS scores did not differ at 3 months. However, total AIMS scores and sitting subscores were significantly higher at 6 months in infants receiving 400 IU/day compared to 800 IU/day and 1,200 IU/day groups (p < .05). There were weak negative correlations with length and C-3 epimer of 25(OH)D. In contrast to our hypothesis, gross motor achievements were significantly higher in infants receiving 400 IU/day vitamin D. Our findings also support longer infants being slightly delayed.

Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial.

PubMed

Amatya, S; Macomber, M; Bhutada, A; Rastogi, D; Rastogi, S

2017-06-01

In preterm infants, nasal continuous positive airway pressure (NCPAP) is widely used for treatment of respiratory distress syndrome. However, the strategies for successfully weaning infants off NCPAP are still not well defined and there remains considerable variation between the methods. The objective of this study is to determine whether gradual weaning of NCPAP pressure is more successful than sudden weaning off NCPAP to room air. A randomized controlled trial was conducted in a level 3 neonatal intensive care unit on 70 preterm neonates who were born between 26 and 32 weeks gestation and required NCPAP for at least 48 h. When infants were stable on NCPAP at 0.21 FiO 2 and 5 cm H 2 O positive end expiratory pressure, neonates were randomized to the gradual wean group (reduction in pressure by 1 cm every 8 h until 3 cm H 2 0 was reached) or to sudden wean group (one time NCPAP removal to room air). The primary outcome was a success at the first trial to wean to room air. Secondary outcomes were a number of trials, and weight and postmenstrual age (PMA) at the time of successful wean. Total number of days on NCPAP and length of stay (LOS) in the hospital were also compared between the groups. Of the 70 infants included in the study, 35 were randomized to sudden group and 33 infants to gradual group (2 excluded for protocol deviation). In sudden and gradual groups, 14 and 22 infants, respectively, were weaned successfully in the first attempt (P=0.03). The infants were successfully weaned at 32.7±1.7 weeks versus 33.1±2.4 weeks (P=0.39) PMA and at a weight of 1651±290 g versus 1589±398 g (P=0.46) in the sudden and gradual groups, respectively. The total number of days on NCPAP was 27±19 days versus 32±24 days (P=0.38) and LOS was 63±25 days versus 63±22 days (P=0.99) in the sudden and gradual groups, respectively. Gradual weaning method was more successful as compared to sudden weaning method in the initial trial off NCPAP. There was no

Mother-infant interaction improves with a developmental intervention for mother-preterm infant dyads.

PubMed

White-Traut, Rosemary; Norr, Kathleen F; Fabiyi, Camille; Rankin, Kristin M; Li, Zhyouing; Liu, Li

2013-12-01

While premature infants have a high need for positive interactions, both infants and their mothers are challenged by the infant's biological immaturity. This randomized clinical trial of 198 premature infants born at 29-34 weeks gestation and their mothers examined the impact of the H-HOPE (Hospital to Home: Optimizing the Infant's Environment) intervention on mother-premature infant interaction patterns at 6-weeks corrected age (CA). Mothers had at least 2 social environmental risk factors such as minority status or less than high school education. Mother-infant dyads were randomly assigned to the H-HOPE intervention group or an attention control group. H-HOPE is an integrated intervention that included (1) twice-daily infant stimulation using the ATVV (auditory, tactile, visual, and vestibular-rocking stimulation) and (2) four maternal participatory guidance sessions plus two telephone calls by a nurse-community advocate team. Mother-infant interaction was assessed at 6-weeks CA using the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST, 76 items) and the Dyadic Mutuality Code (DMC, 6-item contingency scale during a 5-min play session). NCAST and DMC scores for the Control and H-HOPE groups were compared using t-tests, chi-square tests and multivariable analysis. Compared with the Control group (n = 76), the H-HOPE group (n = 66) had higher overall NCAST scores and higher maternal Social-Emotional Growth Fostering Subscale scores. The H-HOPE group also had significantly higher scores for the overall infant subscale and the Infant Clarity of Cues Subscale (p < 0.05). H-HOPE dyads were also more likely to have high responsiveness during play as measured by the DMC (67.6% versus 58.1% of controls). After adjustment for significant maternal and infant characteristics, H-HOPE dyads had marginally higher scores during feeding on overall mother-infant interaction (β = 2.03, p = 0.06) and significantly higher scores on the infant subscale (β = 0.75, p

Health Messaging and African-American Infant Sleep Location: A Randomized Controlled Trial

PubMed Central

Moon, Rachel Y; Mathews, Anita; Joyner, Brandi L.; Oden, Rosalind P.; He, Jianping; McCarter, Robert

2016-01-01

Background Infant-parent bedsharing increases the risk of SIDS and other sleep-related deaths. Despite AAP recommendations to avoid bedsharing, public health efforts have been unsuccessful in changing behaviors. African-American infants are more than twice as likely to die from SIDS and other sleep-related deaths, and are also twice as likely to bedshare with their parents. Further, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation, but low self-efficacy with regards to SIDS risk reduction. It is unclear whether messages emphasizing suffocation prevention will decrease bedsharing. Objectives To evaluate the impact of specific health messages on African-American parental decisions regarding infant sleep location. Methods We conducted a randomized, controlled trial of African-American mothers of infants. The control group received standard messaging emphasizing AAP-recommended safe sleep practices, including avoidance of bedsharing, for the purposes of SIDS risk reduction. The intervention group received enhanced messaging emphasizing safe sleep practices, including avoidance of bedsharing, for both SIDS risk reduction and suffocation prevention. Participants completed interviews at 2–3 weeks, 2–3 months, and 5–6 months after the infant’s birth. Results 1194 mothers were enrolled in the study, and 637 completed all interviews. Bedsharing, both usually (aOR 1.005 [95% CI 1.003, 1.006]) and last night (aOR 1.004 [95% CI 1.002, 1.007]) increased slightly but statistically significantly with infant age (p<0.001). Receipt of the enhanced message did not impact on sleep location. Maternal belief that bedsharing increased the risk of SIDS or suffocation declined over 6 months (p<0.001) and did not differ by group assignment. Conclusion African-American mothers who received an enhanced message about SIDS risk reduction and suffocation prevention were no less likely to bedshare with their infants. PMID:27470122

Does Topical Lidocaine Reduce the Pain Associated With the Insertion of Nasal Continuous Positive Airway Pressure Prongs in Preterm Infants?: A Randomized, Controlled Pilot Trial.

PubMed

Soliman, Hasnaa; Elsharkawy, Ashraf; Abdel-Hady, Hesham

2016-11-01

To evaluate the efficacy of topical lidocaine 2% gel in reducing the pain associated with the insertion of nasal continuous positive airway pressure (nCPAP) prongs in preterm infants. A pilot randomized controlled trial. Sixty preterm infants, categorized into lidocaine (n=30) and control groups (n=30). The primary outcome was Premature Infant Pain Profile (PIPP) score, secondary outcomes included salivary cortisol, presence of cry, the duration of first cry, and adverse effects of lidocaine. There were no statistically significant differences between lidocaine and control groups regarding PIPP scores (mean±SD: 7.2±2.3 vs. 9.3±3.0, respectively, P=0.086). None of the infants in the lidocaine group had severe pain defined as a PIPP score>12, compared with 3 (10%) infants in the control group (P=0.056). Salivary cortisol concentrations were not significantly different between the lidocaine and control groups (mean±SD: 2.57±1.79 vs. 4.82±1.61 μg/dL, respectively, P=0.11). Standardized effect sizes for topical lidocaine were medium to large for reduction in PIPP scores and large for reduction in salivary cortisol (Cohen d=-0.78 and -1.32, respectively). No adverse effects were reported in infants receiving lidocaine. Our data suggest that topical lidocaine did not reduce the pain associated with the insertion of nCPAP prongs in preterm infants. However, the trends for lower PIPP scores in the lidocaine group and the effect sizes for lidocaine on PIPP scores and salivary cortisol were large enough so that a large-scale randomized clinical trial is warranted to confirm or refute our results. Such a study should compare 2 or more active pain interventions during nCPAP application, rather than evaluating a single intervention versus placebo or no treatment.

Head-to-head immunogenicity comparison of Edmonston-Zagreb vs. AIK-C measles vaccine strains in infants aged 8-12 months: A randomized clinical trial.

PubMed

Izadi, Shahrokh; Zahraei, Seyed Mohsen; Salehi, Masoud; Mohammadi, Mahdi; Tabatabaei, Seyed Mehdi; Mokhtari-Azad, Talat

2018-01-29

A non-inferiority multi-centre parallel randomized double-blind trial was implemented in Zahedan district, Sistan-va-Baluchestan province, Iran, to compare the performance of the two measles vaccines which are in use in the National Immunization Programme of Iran and are of two different measles virus vaccine strains: Edmonston-Zagreb (EZ) strain vs. AIK-C strain. The main outcome measure was appearance of anti-measles antibody in sera. 200 infants, 8-12 months old, whose parents consented for their children to be included in the study, were randomized in permutation blocks of size 4-8 in four Urban Health Clinics. Having given a pre-vaccination blood sample, they received measles-rubella vaccine containing one of the vaccine strains mentioned before. After 60 days, the second blood sample was taken. The sera of the pre- and post-vaccination blood samples were tested for anti-measles antibodies in the National Reference Measles Laboratory. Parents, laboratory technicians and statistician were blind to groupings. Of the 200 children equally randomized in the two arms, 185 who were seronegative before vaccination (88 in the EZ arm and 97 in the AIK-C arm) were entered in the final analysis. The seroconversion rate in the EZ arm was 76.1% (95% CI: 60.2-85.2%), and that in the AIK-C arm was 58.7%; (95% CI: 48.8-68.7%). The absolute rate difference was 17. 4% (4.1-30.9%; P-value: .012), and the relative seroconversion rate of EZ to AIK-C was 1.3 (95% CI: 1.1-1.6; P-value: .012). No adverse events were reported during the study period. A considerable difference in the seropositivity of different measles containing vaccines could be demonstrated in the first year of life. Iranian Registry of Clinical Trials Registration Number: IRCT2016032827144N1; May 10, 2016 (www.who.int/ictrp/network/irct/en/). Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of prenatal docosahexaenoic acid supplementation on infant outcomes in African American women living in low-income environments: A randomized, controlled trial.

PubMed

Keenan, Kate; Hipwell, Alison; McAloon, Rose; Hoffmann, Amy; Mohanty, Arpita; Magee, Kelsey

2016-09-01

African American women living in urban, low-income environments are at high risk for poor nutrition during pregnancy and birth complications. To test the effectiveness of prenatal docosahexaenoic acid (DHA) supplementation on birth outcomes and infant development in a sample of African American women with Medicaid insurance and living in the city of Pittsburgh. The Nutrition and Pregnancy Study (NAPS) is a double-blind, randomized controlled trial of prenatal DHA supplementation conducted between 2012 and 2014. Participants were recruited from obstetric clinics at the University of Pittsburgh Medical Center. Sixty-four pregnant, African American women were enrolled at 16-21 weeks of gestation and randomized to either 450mg/day of DHA (22:6n-3)(n=43) or a soybean placebo (n=21). Four women (6.3%) withdrew from the study: two participants from each study arm; complete data were obtained for 49 infants (76.5%) at the 3-month assessment. Supplementation with DHA or placebo continued from the beginning of enrollment through delivery. Data on birth outcomes were collected from medical records. At approximately 3 months post-partum, mothers brought their infants to the laboratory where the Bayley Scales of Infant Development (BSID-III) were administered and cortisol response to the Face-to-Face Still-Face (FFSF) paradigm was assessed. Infants of mothers who received DHA supplementation had higher birth weight (3.174g versus 2.890g) than infants of mothers receiving placebo (F [2.40]=6.09, p=0.018, eta=0.36), and were more likely to have a 1-min Apgar score greater than 8 (OR=5.99 [95% CI=1.25-28.75], p=0.025). Infants of mothers who received DHA compared with infants of mothers receiving placebo had lower levels of cortisol in response to the FFSF paradigm (F [1.32]=5.36, p=0.018, eta=0.36). None of the scores on the BSID-III differed as a function of active supplement versus placebo. Infants of women living in urban, low-income environments who received DHA

Clinicians guide for cue‐based transition to oral feeding in preterm infants: An easy‐to‐use clinical guide

PubMed Central

2017-01-01

Abstract Rationale, aims and objectives This article aims to provide evidence to guide multidisciplinary clinical practitioners towards successful initiation and long‐term maintenance of oral feeding in preterm infants, directed by the individual infant maturity. Method A comprehensive review of primary research, explorative work, existing guidelines, and evidence‐based opinions regarding the transition to oral feeding in preterm infants was studied to compile this document. Results Current clinical hospital practices are described and challenged and the principles of cue‐based feeding are explored. “Traditional” feeding regimes use criteria, such as the infant's weight, gestational age and being free of illness, and even caregiver intuition to initiate or delay oral feeding. However, these criteria could compromise the infant and increase anxiety levels and frustration for parents and caregivers. Cue‐based feeding, opposed to volume‐driven feeding, lead to improved feeding success, including increased weight gain, shorter hospital stay, fewer adverse events, without increasing staff workload while simultaneously improving parents' skills regarding infant feeding. Although research is available on cue‐based feeding, an easy‐to‐use clinical guide for practitioners could not be found. A cue‐based infant feeding regime, for clinical decision making on providing opportunities to support feeding success in preterm infants, is provided in this article as a framework for clinical reasoning. Conclusions Cue‐based feeding of preterm infants requires care providers who are trained in and sensitive to infant cues, to ensure optimal feeding success. An easy‐to‐use clinical guideline is presented for implementation by multidisciplinary team members. This evidence‐based guideline aims to improve feeding outcomes for the newborn infant and to facilitate the tasks of nurses and caregivers. PMID:28251754

Long-Chain Polyunsaturated Fatty Acids and Clinical Outcomes of Preterm Infants.

PubMed

Lapillonne, Alexandre; Moltu, Sissel J

2016-01-01

Long-chain polyunsaturated fatty acids (LCPUFAs) play specific roles during the perinatal period and are very important nutrients to consider. The possible effects of LCPUFAs, particularly docosahexaenoic acid (DHA), on various clinical outcomes of preterm infants are discussed in this paper. Since DHA accumulates in the central nervous system during development, a lot of attention has focused on the effects of DHA on neurodevelopment. Experimental studies as well as recent clinical trials show that providing larger amounts of DHA than currently and routinely provided is associated with better neurological outcomes at 18 months to 2 years. This early advantage, however, does not seem to translate into detectable change in visual and neurodevelopmental outcomes or behavior when assessed in childhood. There is growing evidence that, in addition to effects on development, omega-3 LCPUFAs may reduce the incidence or severity of neonatal morbidities by affecting different steps of the immune and anti-inflammatory response. Studies in preterm infants suggest that the omega-3 LCPUFAs may play a significant role by reducing the risk of bronchopulmonary dysplasia, necrotizing enterocolitis and possibly retinopathy of prematurity and sepsis. Overall, evidence is increasing to support the benefits of high-dose DHA for various health outcomes of preterm infants. These findings are of major clinical relevance mainly because infants born preterm are at particularly high risk for a nutritional deficit in omega-3 fatty acids, predisposing to adverse neonatal outcomes. Further studies are warranted to address these issues as well as to more precisely determine the LCPUFA requirement in order to favor the best possible outcomes of preterm infants. © 2016 S. Karger AG, Basel.

Language skills of young children with unilateral cleft lip and palate following infant orthopedics: a randomized clinical trial.

PubMed

Konst, Emmy M; Rietveld, Toni; Peters, Herman F M; Kuijpers-Jagtman, Anne Marie

2003-07-01

To investigate the effects of infant orthopedics (IO) on the language skills of children with complete unilateral cleft lip and palate (UCLP). In a prospective randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed up longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group); the other group did not receive this treatment (non-IO group). At the ages of 2, 2(1/2), 3, and 6 years, language development was evaluated in 12 children (six IO and six non-IO). Receptive language skills were assessed using the Reynell test. Expressive language skills of the toddlers were evaluated by calculating mean length of utterance (MLU) and mean length of longest utterances (MLLU); in the 6-year-olds, the expressive language skills were measured using standardized Dutch language tests. The participants had complete UCLP without soft tissue bands or other malformations. IO did not affect the receptive language skills. However, the expressive language measures MLU and MLLU were influenced by IO. At age 2(1/2) and 3 years, the IO group produced longer utterances than the non-IO group. In the follow-up, the difference in expressive language between the two groups was no longer significant. Children treated with IO during their first year of life produced longer sentences than non-IO children at the ages of 2(1/2) and 3 years. At 6 years of age, both groups presented similar expressive language skills. Hence, IO treatment did not have long-lasting effects on language development.

Longitudinal Regional Brain Development and Clinical Risk Factors in Extremely Preterm Infants.

PubMed

Kersbergen, Karina J; Makropoulos, Antonios; Aljabar, Paul; Groenendaal, Floris; de Vries, Linda S; Counsell, Serena J; Benders, Manon J N L

2016-11-01

To investigate third-trimester extrauterine brain growth and correlate this with clinical risk factors in the neonatal period, using serially acquired brain tissue volumes in a large, unselected cohort of extremely preterm born infants. Preterm infants (gestational age <28 weeks) underwent brain magnetic resonance imaging (MRI) at around 30 weeks postmenstrual age and again around term equivalent age. MRIs were segmented in 50 different regions covering the entire brain. Multivariable regression analysis was used to determine the influence of clinical variables on volumes at both scans, as well as on volumetric growth. MRIs at term equivalent age were available for 210 infants and serial data were available for 131 infants. Growth over these 10 weeks was greatest for the cerebellum, with an increase of 258%. Sex, birth weight z-score, and prolonged mechanical ventilation showed global effects on brain volumes on both scans. The effect of brain injury on ventricular size was already visible at 30 weeks, whereas growth data and volumes at term-equivalent age revealed the effect of brain injury on the cerebellum. This study provides data about third-trimester extrauterine volumetric brain growth in preterm infants. Both global and local effects of several common clinical risk factors were found to influence serial volumetric measurements, highlighting the vulnerability of the human brain, especially in the presence of brain injury, during this period. Copyright © 2016 Elsevier Inc. All rights reserved.

A new infant hybrid respiratory simulator: preliminary evaluation based on clinical data.

PubMed

Stankiewicz, Barbara; Pałko, Krzysztof J; Darowski, Marek; Zieliński, Krzysztof; Kozarski, Maciej

2017-11-01

A new hybrid (numerical-physical) simulator of the respiratory system, designed to simulate spontaneous and artificial/assisted ventilation of preterm and full-term infants underwent preliminary evaluation. A numerical, seven-compartmental model of the respiratory system mechanics allows the operator to simulate global and peripheral obstruction and restriction of the lungs. The physical part of the simulator is a piston-based construction of impedance transformer. LabVIEW real-time software coordinates the work of both parts of the simulator and its interaction with a ventilator. Using clinical data, five groups of "artificial infants" were examined: healthy full-term infants, very low-birth-weight preterm infants successfully (VLBW) and unsuccessfully extubated (VLBWun) and extremely low-birth-weight preterm infants without (ELBW) and with bronchopulmonary dysplasia (ELBW_BPD). Pressure-controlled ventilation was simulated to measure peak inspiratory pressure, mean airway pressure, total (patient + endotracheal tube) airway resistance (R), total dynamic compliance of the respiratory system (C), and total work of breathing by the ventilator (WOB). The differences between simulation and clinical parameters were not significant. High correlation coefficients between both types of data were obtained for R, C, and WOB (γ R  = 0.99, P < 0.0005; γ C  = 0.85, P < 0.005; γ WOB  = 0.96, P < 0.05, respectively). Thus, the simulator accurately reproduces infant respiratory system mechanics.

Long-Term Maternal Effects of Early Childhood Intervention: Findings from the Infant Health and Development Program (IHDP)

ERIC Educational Resources Information Center

Martin, Anne; Brooks-Gunn, Jeanne; Klebanov, Pamela; Buka, Stephen L.; McCormick, Marie C.

2008-01-01

The Infant Health and Development Program (IHDP) was a randomized clinical trial of early intervention services for low birth weight, premature infants. Mothers and infants received services for 3 years beginning at neonatal discharge. At the intervention's conclusion, mothers in the intervention group who had lighter (less than 2001 g) birth…

A Randomized Control Trial of Cardiopulmonary Feedback Devices and Their Impact on Infant Chest Compression Quality: A Simulation Study.

PubMed

Austin, Andrea L; Spalding, Carmen N; Landa, Katrina N; Myer, Brian R; Donald, Cure; Smith, Jason E; Platt, Gerald; King, Heather C

2017-10-27

In effort to improve chest compression quality among health care providers, numerous feedback devices have been developed. Few studies, however, have focused on the use of cardiopulmonary resuscitation feedback devices for infants and children. This study evaluated the quality of chest compressions with standard team-leader coaching, a metronome (MetroTimer by ONYX Apps), and visual feedback (SkillGuide Cardiopulmonary Feedback Device) during simulated infant cardiopulmonary resuscitation. Seventy voluntary health care providers who had recently completed Pediatric Advanced Life Support or Basic Life Support courses were randomized to perform simulated infant cardiopulmonary resuscitation into 1 of 3 groups: team-leader coaching alone (control), coaching plus metronome, or coaching plus SkillGuide for 2 minutes continuously. Rate, depth, and frequency of complete recoil during cardiopulmonary resuscitation were recorded by the Laerdal SimPad device for each participant. American Heart Association-approved compression techniques were randomized to either 2-finger or encircling thumbs. The metronome was associated with more ideal compression rate than visual feedback or coaching alone (104/min vs 112/min and 113/min; P = 0.003, 0.019). Visual feedback was associated with more ideal depth than auditory (41 mm vs 38.9; P = 0.03). There were no significant differences in complete recoil between groups. Secondary outcomes of compression technique revealed a difference of 1 mm. Subgroup analysis of male versus female showed no difference in mean number of compressions (221.76 vs 219.79; P = 0.72), mean compression depth (40.47 vs 39.25; P = 0.09), or rate of complete release (70.27% vs 64.96%; P = 0.54). In the adult literature, feedback devices often show an increase in quality of chest compressions. Although more studies are needed, this study did not demonstrate a clinically significant improvement in chest compressions with the addition of a metronome or visual

Effect of cup feeding and bottle feeding on breastfeeding in late preterm infants: a randomized controlled study.

PubMed

Yilmaz, Gonca; Caylan, Nilgun; Karacan, Can Demir; Bodur, İlknur; Gokcay, Gulbin

2014-05-01

Cup feeding has been used as an alternative feeding method for preterm infants. The purpose of this study was to determine the effect of bottle and cup feeding on exclusive breastfeeding rates at hospital discharge and 3 and 6 months post-discharge in late preterm infants. Included in the study were preterm infants of 32 to 35 weeks' gestation fed only by intermittent gastric tube at the time of recruitment; 522 infants were randomly assigned to 2 groups: the cup-fed group (n = 254) and bottle-fed group (n = 268). Main outcomes were prevalence of exclusive breastfeeding at discharge and 3 and 6 months after discharge, and length of hospital stay. Infants randomized to cup versus bottle feeding were more likely to be exclusively breastfed at discharge home (relative risk [RR], 1.58; 95% confidence interval [CI], 1.36-1.83), 3 months after discharge (RR, 1.64; 95% CI, 1.42-1.89), and 6 months after discharge (RR, 1.36; 95% CI, 1.14-1.63). There was no significant difference between groups for length of hospital stay. The mean hospital stay was 25.96 ± 2.20 days in the bottle-fed group and 25.68 ± 2.22 days in the cup-fed group. There was no significant difference between groups for time spent feeding, feeding problems, or weight gain in hospital. Cup feeding significantly increased the likelihood of late preterm infants being exclusively breastfed at discharge and 3 and 6 months after discharge, and cup feeding did not increase the length of hospital stay. Overall, we recommend cup feeding as a transitional method prior to breastfeeding for late preterm infants during hospitalization.

MOTHER-INFANT INTERACTION IMPROVES WITH A DEVELOPMENTAL INTERVENTION FOR MOTHER-PRETERM INFANT DYADS

PubMed Central

White-Traut, Rosemary; Norr, Kathleen F.; Fabiyi, Camille; Rankin, Kristin M.; Li, Zhyouing; Liu, Li

2013-01-01

While premature infants have a high need for positive interactions, both infants and their mothers are challenged by the infant‘s biological immaturity. This randomized clinical trial of 198 premature infants born at 29–34 weeks gestation and their mothers examined the impact of the H-HOPE (Hospital to Home: Optimizing the Infant’s Environment) intervention on mother-premature infant interaction patterns at 6-weeks corrected age (CA). Mothers had at least 2 social environmental risk factors such as minority status or less than high school education. Mother-infant dyads were randomly assigned to the H-HOPE intervention group or an attention Control group. H-HOPE is an integrated intervention that included (1) twice-daily infant stimulation using the ATVV (auditory, tactile, visual, and vestibular-rocking stimulation) and (2) four maternal participatory guidance sessions plus two telephone calls by a nurse-community advocate team. Mother-infant interaction was assessed at 6-weeks CA using the Nursing Child Assessment Satellite Training–Feeding Scale (NCAST, 76 items) and the Dyadic Mutuality Code (DMC, 6-item contingency scale during a 5-minute play session). NCAST and DMC scores for the Control and H-HOPE groups were compared using t-tests, chi-square tests and multivariable analysis. Compared with the Control group (n = 76), the H-HOPE group (n = 66) had higher overall NCAST scores and higher maternal Social-Emotional Growth Fostering Subscale scores. The H-HOPE group also had significantly higher scores for the overall infant subscale and the Infant Clarity of Cues Subscale (p < 0.05). H-HOPE dyads were also more likely to have high responsiveness during play as measured by the DMC (67.6% versus 58.1% of controls). After adjustment for significant maternal and infant characteristics, H-HOPE dyads had marginally higher scores during feeding on overall mother-infant interaction (β = 2.03, p = .06) and significantly higher scores on the infant subscale (�

Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial.

PubMed

Girgin, Burcu Aykanat; Gözen, Duygu; Karatekin, Güner

2018-04-01

The aim of this randomized controlled study was to determine the effect of semielevated side-lying (ESL) and semielevated supine (ESU) positions, which are used to bottle-feed preterm infants, on their physiological characteristics and feeding performance. The sample consisted of preterm infants who were born in the 31st gestational week and below, and met the inclusion criteria. A randomization was provided in the sample group with a total of 80 infants including 38 infants in the ESL (experimental) group and 42 infants in the ESU (control) group. Both groups were compared in terms of their SpO2 values, heart rates, and feeding performances before, during, and after the feeding. The data were obtained by using a form for infant descriptive characteristics, feeding follow-up form, a Masimo Radical-7 pulse oximeter device, and a video camera. It was determined that the infants in the ESL group had statistically significantly higher SpO2 values (ESL: 96.77 ± 2.51; ESU: 93.48 ± 5.63) and lower heart rates (ESL: 155.87 ± 11.18; ESU: 164.35 ± 6.00) during the feeding compared to the infants in the ESU group (p < .05). Besides, oxygen saturation levels of the infants in the ESU group decreased more (p < .01) and their heart rates increased more (p < .05) during the feeding than those obtained before the feeding compared to the infants in the ESL group. The ESL position has a more positive effect on oxygen saturation and heart rate of infants and it is more effective in providing a physiological stabilization during the feeding, compared to the ESU position. According to these results, the ESL position can be recommended for preterm feeding. © 2018 Wiley Periodicals, Inc.

Effectiveness of supplementary blended flour based on chickpea and cereals for the treatment of infants with moderate acute malnutrition in Iran: A randomized clinical trial.

PubMed

Javan, Roghayeh; Kooshki, Akram; Afzalaghaee, Monavvar; Aldaghi, Mitra; Yousefi, Mahdi

2017-12-01

Despite the decreasing rate of under nutrition children in recent years overall, the negative affect in growth and development make it as a main concern in the world. Applying an available and appropriate supplementary food is a major approach in treating children with Moderate Acute Malnutrition (MAM). To compare the effectiveness of a new supplementary blended flour (containing chickpea, rice, wheat and barley, named Shadameen) in combination with multivitamin/mineral supplement and nutritional counseling versus multivitamin/mineral supplement and nutritional counseling alone, in the treatment of children with MAM. This randomized controlled trial study was conducted at Heshmatiyeh Hospital in Sabzevar city in Iran, from January 2016 to December 2016. Seventy infants, aged 9 to 24 months with MAM who were referred from urban health centers to the hospital clinic were included. They were randomly assigned to receive, for about 3 months, either multivitamin / mineral supplement and nutritional counseling alone or in combination with an extra supplementary blended food. We analyzed weight, length, weight for length Z score (WLZ), weight for age Z score (WAZ) and length for weight Z score (LAZ), along with recovery rate and adverse events among the two groups. The data were analyzed using SPSS version 16. We used statistics, Chi-square, independent t-test, and Fisher's exact test for the analyses of primary and secondary outcomes. The food supplementation infant's mean weight and WLZ and WAZ were greater compared with the other group (0.81±0.29 gr and 0.55±0.33 gr, p=0.002), (0.36±0.36 and 0.02±0.52, p=0.003), (0.40±0.33 and 0.09±0.37, p=0.001). The recovery rate in the food supplemented group was significantly higher than the other group (68.4%, 31.6%, p=0.001). No adverse reactions were observed. There were no significant differences in LAZ at the end of the study between the two groups (p=0.53). This study showed that Shadameen in combination with

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial

PubMed Central

López-Velázquez, Gabriel; Parra-Ortiz, Minerva; De la Mora-De la Mora, Ignacio; García-Torres, Itzhel; Enríquez-Flores, Sergio; Alcántara-Ortigoza, Miguel Angel; González-del Angel, Ariadna; Velázquez-Aragón, José; Ortiz-Hernández, Rosario; Cruz-Rubio, José Manuel; Villa-Barragán, Pablo; Jiménez-Gutiérrez, Carlos; Gutiérrez-Castrellón, Pedro

2015-01-01

Background: The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin® and Metlos®) was demonstrated. Methods: This study aimed to demonstrate the efficacy as prebiotics of Metlin® and Metlos® in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. Results: There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin® and Metlos®. Conclusions: Our results support the efficacy of Metlin® and Metlos® as prebiotics in humans, and stand the bases to recommend their consumption. Trial Registration: ClinicalTrials.gov, NCT 01251783. PMID:26529006

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial.

PubMed

López-Velázquez, Gabriel; Parra-Ortiz, Minerva; Mora, Ignacio De la Mora-De la; García-Torres, Itzhel; Enríquez-Flores, Sergio; Alcántara-Ortigoza, Miguel Angel; Angel, Ariadna González-Del; Velázquez-Aragón, José; Ortiz-Hernández, Rosario; Cruz-Rubio, José Manuel; Villa-Barragán, Pablo; Jiménez-Gutiérrez, Carlos; Gutiérrez-Castrellón, Pedro

2015-10-29

The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin(®) and Metlos(®)) was demonstrated. This study aimed to demonstrate the efficacy as prebiotics of Metlin(®) and Metlos(®) in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin(®) and Metlos(®). Our results support the efficacy of Metlin(®) and Metlos(®) as prebiotics in humans, and stand the bases to recommend their consumption. ClinicalTrials.gov, NCT 01251783.

Infant botulism.

PubMed

Fenicia, Lucia; Anniballi, Fabrizio

2009-01-01

Infant botulism is a rare disease that affects infant less than 12 months of age. The illness results from absorption of botulinum toxin produced in situ by neurotoxigenic clostridia that can temporarily colonize the intestinal tract of infants. To date, all inhabited continents except Africa have reported cases of infant botulism. Recognition of cases seem directly related to physician awareness and clinical suspicion. This review summarizes microbiological, clinical and epidemiological features of infant botulism.

Oral Microbiota in Infants Fed a Formula Supplemented with Bovine Milk Fat Globule Membranes - A Randomized Controlled Trial.

PubMed

Timby, Niklas; Domellöf, Magnus; Holgerson, Pernilla Lif; West, Christina E; Lönnerdal, Bo; Hernell, Olle; Johansson, Ingegerd

2017-01-01

In a recent study, supplementation of infant formula with milk fat globule membranes (MFGM) decreased the incidence of otitis media in infants <6 months of age. The aim of the present study was to characterize the oral microbiota in infants fed MFGM-supplemented formula and compare it to that of infants fed standard formula or breast milk. In a prospective double-blinded randomized controlled trial, exclusively formula-fed infants <2 months of age were randomized to be fed experimental formula (EF, n = 80) with reduced energy and protein and supplemented with a bovine MFGM concentrate, or standard formula (SF, n = 80) until 6 months of age. A breast-fed reference (BFR, n = 80) group was also recruited. The oral microbiota was analyzed at 4 (n = 124) and 12 (n = 166) months of age using Illumina MiSeq multiplex sequencing and taxonomic resolution against the HOMD 16S rDNA database of oral bacteria. Species richness in the oral samples did not differ between the EF and SF groups, but partial least square modeling identified a few taxa that were significantly associated with being in either group, e.g. lower level of Moraxella catarrhalis in the EF group. Infants in the BFR group had significantly lower species richness at 4 months of age and their microbiota pattern differed markedly from the formula-fed groups. Supplementation of infant formula with MFGM yielded moderate effects on the oral microbiome. Moraxella catarrhalis was less prevalent in infants fed EF than in those fed SF and may be associated with the decrease in otitis media seen in the same group.

Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia.

PubMed

Bines, Julie E; Liem, Nguyen Thanh; Justice, Frances; Son, Tran Ngoc; Carlin, John B; de Campo, Margaret; Jamsen, Kris; Mulholland, Kim; Barnett, Peter; Barnes, Graeme L

2006-07-01

To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition of intussusception. Diagnosis of intussusception was confirmed by air enema or surgery and validated in a subset of participants by an independent clinician who was blinded to the participant's status. Sensitivity of the definition was evaluated in 584 infants aged<2 years with suspected intussusception (533 infants in Hanoi; 51 in Melbourne). Specificity was evaluated in 638 infants aged<2 years presenting with clinical features consistent with intussusception but for whom another diagnosis was established (234 infants in Hanoi; 404 in Melbourne). In both locations the definition used was sensitive (96% sensitivity in Hanoi; 98% in Melbourne) and specific (95% specificity in Hanoi; 87% in Melbourne) for intussusception among infants with sufficient data to allow classification (449/533 in Hanoi; 50/51 in Melbourne). Reanalysis of patients with missing data suggests that modifying minor criteria would increase the applicability of the definition while maintaining good sensitivity (96-97%) and specificity (83-89%). The clinical case definition was sensitive and specific for the diagnosis of acute intussusception in infants in both a developing country and a developed country but minor modifications would enable it to be used more widely.

Saccharomyces boulardii for prevention of necrotizing enterocolitis in preterm infants: a randomized, controlled study.

PubMed

Demirel, Gamze; Erdeve, Omer; Celik, Istemi Han; Dilmen, Ugur

2013-12-01

To evaluate the efficacy of orally administered Saccharomyces boulardii (S. boulardii) for reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low-birth-weight (VLBW) infants. A prospective, randomised controlled trial was conducted in infants with gestational age ≤32 weeks and birth weight ≤1500 g. The study group received S. boulardii supplementation, and the control group did not. The primary outcomes were death or NEC (Bell's stage ≥2), and secondary outcomes were feeding intolerance and clinical or culture-proven sepsis. A total of 271 infants were enrolled in the study, 135 in the study group and 136 in the control group. There was no significant difference in the incidence of death (3.7% vs. 3.6%, 95% CI of the difference, -5.20-5.25; p = 1.0) or NEC (4.4% vs. 5.1%, 95% CI, -0.65-5.12; p = 1.0) between the groups. However, feeding intolerance and clinical sepsis were significantly lower in the probiotic group compared with control. Although Saccharomyces boulardii supplementation at a dose of 250 mg/day was not effective at reducing the incidence of death or NEC in VLBW infants, it improved feeding tolerance and reduced the risk of clinical sepsis. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

PubMed

Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

2013-12-01

To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

Low-Dose Iron Supplementation in Infancy Modestly Increases Infant Iron Status at 9 Mo without Decreasing Growth or Increasing Illness in a Randomized Clinical Trial in Rural China123

PubMed Central

Lozoff, Betsy; Jiang, Yaping; Li, Xing; Zhou, Min; Richards, Blair; Xu, Guobin; Clark, Katy M; Liang, Furong; Kaciroti, Niko; Zhao, Gengli; Santos, Denise CC; Zhang, Zhixiang; Tardif, Twila; Li, Ming

2016-01-01

Background: Previous trials of iron supplementation in infancy did not consider maternal iron supplementation. Objective: This study assessed effects of iron supplementation in infancy and/or pregnancy on infant iron status, illnesses, and growth at 9 mo. Methods: Enrollment occurred from December 2009 to June 2012 in Hebei, China. Infants born to women in a pregnancy iron supplementation trial were randomly assigned 1:1 to iron [∼1 mg Fe/(kg · d) as oral iron proteinsuccynilate] or placebo from 6 wk to 9 mo, excluding infants with cord ferritin <35 μg/L. Study groups were pregnancy placebo/infancy placebo (placebo/placebo), pregnancy placebo/infancy iron (placebo/iron), pregnancy iron/infancy placebo (iron/placebo), and pregnancy iron/infancy iron (iron/iron). The primary outcome was 9-mo iron status: iron deficiency (ID) by cutoff (≥2 abnormal iron measures) or body iron <0 mg/kg and ID + anemia (hemoglobin <110 g/L). Secondary outcomes were doctor visits or hospitalizations and weight or length gain from birth to 9 mo. Statistical analysis by intention to treat and dose-response (between number of iron bottles received and outcome) used logistic regression with concomitant RRs and general linear models, with covariate control as applicable. Results: Of 1482 infants randomly allocated, 1276 had 9-mo data (n = 312–327/group). Iron supplementation in infancy, but not pregnancy, reduced ID risk: RRs (95% CIs) were 0.89 (0.79, 0.998) for placebo/iron compared to placebo/placebo, 0.79 (0.63, 0.98) for placebo/iron compared to iron/placebo, 0.87 (0.77, 0.98) for iron/iron compared to placebo/placebo, and 0.86 (0.77, 0.97) for iron/iron compared to iron/placebo. However, >60% of infants still had ID at 9 mo. Receiving more bottles of iron in infancy was associated with better infant iron status at 9 mo but only among iron-supplemented infants whose mothers were also iron supplemented (i.e., the iron/iron group). There were no group differences in

Intermittent Preventive Treatment for Malaria in Papua New Guinean Infants Exposed to Plasmodium falciparum and P. vivax: A Randomized Controlled Trial

PubMed Central

Stanisic, Danielle I.; Robinson, Leanne; Barnadas, Céline; Manong, Doris; Salib, Mary; Iga, Jonah; Tarongka, Nandao; Ley, Serej; Rosanas-Urgell, Anna; Aponte, John J.; Zimmerman, Peter A.; Beeson, James G.; Schofield, Louis; Siba, Peter; Rogerson, Stephen J.; Reeder, John C.; Mueller, Ivo

2012-01-01

Background Intermittent preventive treatment in infants (IPTi) has been shown in randomized trials to reduce malaria-related morbidity in African infants living in areas of high Plasmodium falciparum (Pf) transmission. It remains unclear whether IPTi is an appropriate prevention strategy in non-African settings or those co-endemic for P. vivax (Pv). Methods and Findings In this study, 1,121 Papua New Guinean infants were enrolled into a three-arm placebo-controlled randomized trial and assigned to sulfadoxine-pyrimethamine (SP) (25 mg/kg and 1.25 mg/kg) plus amodiaquine (AQ) (10 mg/kg, 3 d, n = 374), SP plus artesunate (AS) (4 mg/kg, 3 d, n = 374), or placebo (n = 373), given at 3, 6, 9 and 12 mo. Both participants and study teams were blinded to treatment allocation. The primary end point was protective efficacy (PE) against all episodes of clinical malaria from 3 to 15 mo of age. Analysis was by modified intention to treat. The PE (compared to placebo) against clinical malaria episodes (caused by all species) was 29% (95% CI, 10–43, p≤0.001) in children receiving SP-AQ and 12% (95% CI, −11 to 30, p = 0.12) in those receiving SP-AS. Efficacy was higher against Pf than Pv. In the SP-AQ group, Pf incidence was 35% (95% CI, 9–54, p = 0.012) and Pv incidence was 23% (95% CI, 0–41, p = 0.048) lower than in the placebo group. IPTi with SP-AS protected only against Pf episodes (PE = 31%, 95% CI, 4–51, p = 0.027), not against Pv episodes (PE = 6%, 95% CI, −24 to 26, p = 0.759). Number of observed adverse events/serious adverse events did not differ between treatment arms (p>0.55). None of the serious adverse events were thought to be treatment-related, and the vomiting rate was low in both treatment groups (1.4%–2.0%). No rebound in malaria morbidity was observed for 6 mo following the intervention. Conclusions IPTi using a long half-life drug combination is efficacious for the prevention of malaria and anemia in

Refining the Use of Nasal High-Flow Therapy as Primary Respiratory Support for Preterm Infants.

PubMed

Manley, Brett J; Roberts, Calum T; Frøisland, Dag H; Doyle, Lex W; Davis, Peter G; Owen, Louise S

2018-05-01

To identify clinical and demographic variables that predict nasal high-flow (nHF) treatment failure when used as a primary respiratory support for preterm infants. This secondary analysis used data from a multicenter, randomized, controlled trial comparing nHF with continuous positive airway pressure as primary respiratory support in preterm infants 28-36 completed weeks of gestation. Treatment success or failure with nHF was determined using treatment failure criteria within the first 72 hours after randomization. Infants in whom nHF treatment failed received continuous positive airway pressure, and were then intubated if failure criteria were again met. There were 278 preterm infants included, with a mean gestational age (GA) of 32.0 ± 2.1 weeks and a birth weight of 1737 ± 580 g; of these, nHF treatment failed in 71 infants (25.5%). Treatment failure was moderately predicted by a lower GA and higher prerandomization fraction of inspired oxygen (FiO 2 ): area under a receiver operating characteristic curve of 0.76 (95% CI, 0.70-0.83). Nasal HF treatment success was more likely in infants born at ≥30 weeks GA and with prerandomization FiO 2 <0.30. In preterm infants ≥28 weeks' GA enrolled in a randomized, controlled trial, lower GA and higher FiO 2 before randomization predicted early nHF treatment failure. Infants were more likely to be successfully treated with nHF from soon after birth if they were born at ≥30 weeks GA and had a prerandomization FiO 2 <0.30. However, even in this select population, continuous positive airway pressure remains superior to nHF as early respiratory support in preventing treatment failure. Australian New Zealand Clinical Trials Registry: ACTRN12613000303741. Copyright © 2018 Elsevier Inc. All rights reserved.

No effect of adding dairy lipids or long chain polyunsaturated fatty acids on formula tolerance and growth in full term infants: a randomized controlled trial.

PubMed

Gianni, Maria Lorella; Roggero, Paola; Baudry, Charlotte; Fressange-Mazda, Catherine; le Ruyet, Pascale; Mosca, Fabio

2018-01-22

When breastfeeding is not possible, infants are fed formulas in which lipids are usually of plant origin. However, the use of dairy fat in combination with plant oils enables a lipid profile in formula closer to breast milk in terms of fatty acid composition, triglyceride structure and cholesterol content. The objectives of this study were to investigate the impact on growth and gastrointestinal tolerance of a formula containing a mix of dairy lipids and plant oils in healthy infants. This study was a monocentric, double-blind, controlled, randomized trial. Healthy term infants aged less than 3 weeks whose mothers did not breastfeed were randomly allocated to formula containing either: a mix of plant oils and dairy fat (D), only plant oils (P) or plant oils supplemented with long-chain polyunsaturated fatty acids (PDHA). Breastfed infants were included in a reference group (BF). Anthropometric parameters and body composition were measured after 2 and 4 months. Gastrointestinal tolerance was evaluated during 2 day-periods after 1 and 3 months thanks to descriptive parameters reported by parents. Nonrandomized BF infants were not included in the statistical analysis. Eighty eight formula-fed and 29 BF infants were enrolled. Gains of weight, recumbent length, cranial circumference and fat mass were similar between the 3 formula-fed groups at 2 and 4 months and close to those of BF. Z-scores for weight, recumbent length and cranial circumference in all groups were within normal ranges for growth standards. No significant differences were noted among the 3 formula groups in gastrointestinal parameters (stool frequency/consistency/color), occurrence of gastrointestinal symptoms (abdominal pain, flatulence, regurgitation) or infant's behavior. A formula containing a mix of dairy lipids and plant oils enables a normal growth in healthy newborns. This formula is well tolerated and does not lead to abnormal gastrointestinal symptoms. Consequently, reintroduction of

The treatment of patent ductus arteriosus in preterm infants. A review and overview of randomized trials.

PubMed

Knight, D B

2001-02-01

Patent ductus arteriosus (PDA) is a common problem in very preterm infants. It results in a significant left-to-right shunt and an increase in left ventricular output. Pulmonary compliance can be reduced. Systemic effects result from the diastolic steal and retrograde diastolic blood flow. Randomized controlled trials of PDA closure fall into three groups: (i) prophylactic treatment in the first 24 h, (ii) pre-symptomatic treatment on ultrasound evidence of a PDA or the first clinical signs and (iii) treatment when it becomes haemodynamically significant. Prophylactic treatment with indomethacin reduces the incidence of intraventricular haemorrhage. All the trials have a decreased need to treat a subsequent PDA in the treatment group. There are no other improvements in outcome, without any change in mortality, bronchopulmonary dysplasia, necrotizing enterocolitis or retinopathy of prematurity. Clinical decisions on the treatment of the ductus should be individualized and based on the gestation of the baby, the respiratory condition and the size of the ductal shunt. Copyright 2001 Harcourt Publishers Ltd.

[Clinical features and magnetic resonance imaging evaluation of encephalopathy in high-risk late preterm infants].

PubMed

Zhu, Yan; Zhang, Ke; Hu, Lan; Xiao, Mi-Li; Li, Zhi-Hua; Chen, Chao

2017-05-01

To investigate the risk factors, clinical features, and magnetic resonance imaging (MRI) changes of encephalopathy in high-risk late preterm infants. Head MRI scan was performed for late preterm infants with high-risk factors for brain injury who were hospitalized between January 2009 and December 2014. The risk factors, clinical features, and head MRI features of encephalopathy in late preterm infants were analyzed. A total of 1 007 late preterm infants underwent MRI scan, among whom 313 (31.1%) had imaging features in accordance with the features of encephalopathy of prematurity. Of all infants, 76.7% had white matter damage. There was no association between the development of encephalopathy and gestational age in late preterm infants, but the detection rate of encephalopathy gradually increased with the increasing birth weight (P<0.05). The logistic regression analysis showed that a history of resuscitation was an independent risk factor for encephalopathy of prematurity (P<0.01). Encephalopathy of prematurity is commonly seen in high-risk late preterm infants, especially white matter damage. A history of resuscitation is an independent risk factor for encephalopathy in late preterm infants.

Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial.

PubMed

Sudfeld, Christopher R; Manji, Karim P; Duggan, Christopher P; Aboud, Said; Muhihi, Alfa; Sando, David M; Al-Beity, Fadhlun M Alwy; Wang, Molin; Fawzi, Wafaie W

2017-09-04

Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D 3 supplementation may improve the health of HIV-infected pregnant women and their children. The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D 3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12-27 weeks gestation are randomized to either: 1) 3000 IU vitamin D 3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes. The ToV5 will provide causal evidence on the effect of vitamin D 3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach. ClinicalTrials.gov identifier: NCT02305927

A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants.

PubMed

Martinon-Torres, Federico; Gimenez-Sanchez, Francisco; Bernaola-Iturbe, Enrique; Diez-Domingo, Javier; Jiang, Qin; Perez, John L

2014-09-08

Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in infants. A conserved, surface-exposed lipoprotein, LP2086 (a factor H-binding protein [fHBP]), is a promising MnB vaccine target. A bivalent, recombinant vaccine targeting the fHBP (rLP2086) of MnB was developed. This phase 1/2 clinical study was designed to assess the immunogenicity, safety, and tolerability of a 4-dose series of the rLP2086 vaccine at 20-, 60-, 120-, or 200-μg dose levels in vaccine-naive infants when given with routine childhood vaccines. The study was to consist of two phases: a single-blind sentinel phase and an open-label full enrollment phase. During the sentinel phase, randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort. The full enrollment phase was to occur after completion of the sentinel phase. Local reactions were generally mild and adverse events infrequent; however, after only 46 infants were randomized into the study, fever rates were 64% and 90% in subjects receiving one 20- or 60-μg rLP2086 dose, respectively. Most fevers were <39.0°C. Only 2 subjects in the 20-μg group and 1 subject in the 60-μg group experienced fevers >39.0°C; no fevers were >40.0°C. Due to these high fever rates, the study was terminated early. No immunogenicity data were collected. This report discusses the safety and acceptability of rLP2086 in infants after one 20- or 60-μg dose. Due to the high fever rate experienced in the 20- and 60-μg groups, rLP2086 in the current formulation may not be acceptable for infants. Copyright © 2014. Published by Elsevier Ltd.

Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants

USDA-ARS?s Scientific Manuscript database

Our objective was to compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human...

Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants.

PubMed

Demmelmair, Hans; Prell, Christine; Timby, Niklas; Lönnerdal, Bo

2017-07-28

The provision of essential and non-essential amino acids for breast-fed infants is the major function of milk proteins. In addition, breast-fed infants might benefit from bioactivities of milk proteins, which are exhibited in the intestine during the digestive phase and by absorption of intact proteins or derived peptides. For lactoferrin, osteopontin and milk fat globule membrane proteins/lipids, which have not until recently been included in substantial amounts in infant formulas, in vitro experiments and animal models provide a convincing base of evidence for bioactivities, which contribute to the protection of the infant from pathogens, improve nutrient absorption, support the development of the immune system and provide components for optimal neurodevelopment. Technologies have become available to obtain these compounds from cow´s milk and the bovine compounds also exhibit bioactivities in humans. Randomized clinical trials with experimental infant formulas incorporating lactoferrin, osteopontin, or milk fat globule membranes have already provided some evidence for clinical benefits. This review aims to compare findings from laboratory and animal experiments with outcomes of clinical studies. There is good justification from basic science and there are promising results from clinical studies for beneficial effects of lactoferrin, osteopontin and the milk fat globule membrane complex of proteins and lipids. Further studies should ideally be adequately powered to investigate effects on clinically relevant endpoints in healthy term infants.

Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants

PubMed Central

Prell, Christine; Timby, Niklas; Lönnerdal, Bo

2017-01-01

The provision of essential and non-essential amino acids for breast-fed infants is the major function of milk proteins. In addition, breast-fed infants might benefit from bioactivities of milk proteins, which are exhibited in the intestine during the digestive phase and by absorption of intact proteins or derived peptides. For lactoferrin, osteopontin and milk fat globule membrane proteins/lipids, which have not until recently been included in substantial amounts in infant formulas, in vitro experiments and animal models provide a convincing base of evidence for bioactivities, which contribute to the protection of the infant from pathogens, improve nutrient absorption, support the development of the immune system and provide components for optimal neurodevelopment. Technologies have become available to obtain these compounds from cow´s milk and the bovine compounds also exhibit bioactivities in humans. Randomized clinical trials with experimental infant formulas incorporating lactoferrin, osteopontin, or milk fat globule membranes have already provided some evidence for clinical benefits. This review aims to compare findings from laboratory and animal experiments with outcomes of clinical studies. There is good justification from basic science and there are promising results from clinical studies for beneficial effects of lactoferrin, osteopontin and the milk fat globule membrane complex of proteins and lipids. Further studies should ideally be adequately powered to investigate effects on clinically relevant endpoints in healthy term infants. PMID:28788066

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This

Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review

PubMed Central

2012-01-01

Background Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Methods Cochrane methodology was followed using randomized controlled trials (RCTs) which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Results Three synbiotic studies (N = 475), 10 probiotics studies (N = 933) and 12 prebiotics studies (N = 1563) were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal microflora. The

Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review.

PubMed

Mugambi, Mary N; Musekiwa, Alfred; Lombard, Martani; Young, Taryn; Blaauw, Reneé

2012-10-04

Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Cochrane methodology was followed using randomized controlled trials (RCTs) which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Three synbiotic studies (N = 475), 10 probiotics studies (N = 933) and 12 prebiotics studies (N = 1563) were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal microflora. The quality of evidence was

Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes.

PubMed

Darlow, Brian A; Marschner, Simone L; Donoghoe, Mark; Battin, Malcolm R; Broadbent, Roland S; Elder, Mark J; Hewson, Michael P; Meyer, Michael P; Ghadge, Alpana; Graham, Patricia; McNeill, Nicolette J; Kuschel, Carl A; Tarnow-Mordi, William O

2014-07-01

To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation. A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness. The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%. Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants. Copyright © 2014 Elsevier Inc. All rights reserved.

Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial.

PubMed

Price, Anna M H; Wake, Melissa; Ukoumunne, Obioha C; Hiscock, Harriet

2012-10-01

Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P = .8) and conduct behavior scores (P = .6), sleep problems (9% vs 7%, P = .2), sleep habits score (P = .4), parent- (P = .7) and child-reported (P = .8) psychosocial functioning, chronic stress (29% vs 22%, P = .4); (2) child-parent closeness (P = .1) and conflict (P = .4), global relationship (P = .9), disinhibited attachment (P = .3); and (3) parent depression, anxiety, and stress scores (P = .9) or authoritative parenting (63% vs 59%, P = .5). Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

Randomized controlled trial of a home-visiting intervention on infant cognitive development in peri-urban South Africa.

PubMed

Murray, Lynne; Cooper, Peter; Arteche, Adriane; Stein, Alan; Tomlinson, Mark

2016-03-01

To determine whether, in an impoverished South African community, an intervention that benefitted infant attachment also benefitted cognitive development. Pregnant females were randomized to intervention (n=220) and no-treatment control groups (n=229). The intervention was home-based parenting support for attachment, delivered until 6 months postpartum. At 18 months, infants were assessed on attachment and cognitive development (Bayley Scales Mental Development Index [MDI]) (n=127 intervention, n=136 control participants). Infant MDI was examined in relation to intervention, socio-economic risk, antenatal depression, and infant sex and attachment. Overall, there was little effect of the intervention on MDI (p=0.094, d=0.20), but there was an interaction between intervention and risk (p=0.03, ηp2=0.02). MDI scores of infants of lower risk intervention group mothers were, on average, 4.84 points higher than those of other infants (p=0.002, d=0.41). Antenatal depression was not significant once intervention and risk were controlled (p=0.08); there was no association between infant MDI and either sex (p=0.41) or attachment (p=0.56). Parenting interventions for infant cognitive development may benefit from inclusion of specific components to support infant cognition beyond those that support attachment, and may be most effective for infants over 6 months. They may need augmentation with other input where adversity is extreme. © 2015 Mac Keith Press.

Health departments do it better: prenatal care site and prone infant sleep position.

PubMed

Lahr, Martin B; Rosenberg, Kenneth D; Lapidus, Jodi A

2005-06-01

Reduction of prone infant sleep position has been the main public health effort to reduce the incidence of Sudden Infant Death Syndrome (SIDS). Oregon Pregnancy Risk Assessment Monitoring System (PRAMS) surveys a stratified random sample of women after a live birth. In 1998-1999, 1867 women completed the survey (64.0% unweighted response; 73.5% weighted response). Overall, 9.2% of all women "usually" chose prone infant sleep position, while 24.2% chose side and 66.5% chose supine position. Women receiving care from private physicians or HMOs more often chose prone position (10.6%) than women receiving prenatal care from health department clinics (2.5%), hospital clinics (6.1%) or other sites (8.3%). Compared to health department prenatal clinic patients, private prenatal patients were more likely to choose prone infant sleep position, adjusted odds ratio = 4.78 (95% confidence interval [CI] 1.64-13.92). Health Department clinics have done a better job than private physicians in educating mothers about putting infants to sleep on their backs. Providers-especially private providers-should continue to stress the importance of supine sleep position for infants.

Early Intervention for Preterm Infants and Their Mothers: A Systematic Review.

PubMed

Zhang, Xin; Kurtz, Melissa; Lee, Shih-Yu; Liu, Huaping

2014-11-18

This systematic review evaluates the efficacy of various early interventions on maternal emotional outcomes, mother-infant interaction, and subsequent infant outcomes during neonatal intensive care unit admission and postdischarge. Key interventions associated with outcomes in both the neonatal intensive care unit and postdischarge (ie, home) settings are summarized. A comprehensive search of peer-reviewed randomized controlled trials involving early interventions for infants and their mother published between 1993 and 2013 in the electronic databases PubMed, CINAHL, EMBASE, PsychINFO, and Cochrane was undertaken. Methodological quality was assessed using the PEDro scale to evaluate internal and external validity of the study. Twelve randomized controlled trials were included in the review, and all used some form of parenting education. The interventions had limited effects on maternal stress and mother-infant interaction and positive effects on maternal anxiety, depressive symptoms, and maternal coping. There were positive effects on infants' short-term outcomes for length of stay and breast-feeding rate. Positive and clinically meaningful effects of early interventions were seen in some physiological/psychological outcomes of mothers and preterm infants. It is important for nurses to foster close mother-infant contact and increase maternal competence during and after the infant's hospitalization period.

Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial.

PubMed

Johnston, William H; Ashley, Claude; Yeiser, Michael; Harris, Cheryl L; Stolz, Suzanne I; Wampler, Jennifer L; Wittke, Anja; Cooper, Timothy R

2015-11-07

Human milk provides necessary macronutrients (protein, carbohydrate, fat) required for infant nutrition. Lactoferrin (Lf), a multifunctional iron-binding protein predominant in human milk, shares similar protein sequence, structure, and bioactivity with bovine Lf (bLf). This large-scale pediatric nutrition study was designed to evaluate growth and tolerance in healthy infants who received study formulas with bLf at concentrations within the range of mature human milk. In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 480 infants were randomized to receive a marketed routine cow's milk-based infant formula (Control; n = 155) or one of two investigational formulas with bLf at 0.6 g/L (LF-0.6; n = 165) or 1.0 g/L (LF-1.0; n = 160) from 14-365 days of age. Investigational formulas also had a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) and adjusted arachidonic acid (ARA). The primary outcome was weight growth rate from 14-120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, 120, 180, 275, and 365 days of age. Parental recall of formula intake, tolerance, and stool characteristics was collected at each time point. Medically-confirmed adverse events were collected throughout the study period. There were no group differences in growth rate (g/day) from 14-120 days of age; 353 infants completed the study through 365 days of age ( 110; LF-0.6: 127; LF-1.0: 116). Few differences in growth, formula intake, and infant fussiness or gassiness were observed through 365 day of age. Group discontinuation rates and the overall group incidence of medically-confirmed adverse events were not significantly different. From 30 through 180 days of age, group differences in stool consistency (P < 0.005) were detected with softer stools for infants in the LF-0.6 and LF-1.0 groups versus CONTROL. Compared to the Control, infants who received investigational formulas with bLf and the

Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings.

PubMed

Cattaneo, A; Davanzo, R; Worku, B; Surjono, A; Echeverria, M; Bedri, A; Haksari, E; Osorno, L; Gudetta, B; Setyowireni, D; Quintero, S; Tamburlini, G

1998-09-01

A randomized controlled trial was carried out for 1 y in three tertiary and teaching hospitals, in Addis Ababa (Ethiopia), Yogyakarta (Indonesia) and Merida (Mexico), to study the effectiveness, feasibility, acceptability and cost of kangaroo mother care (KMC) when compared to conventional methods of care (CMC). About 29% of 649 low birthweight infants (LBWI; 1000-1999 g) died before eligibility. Of the survivors, 38% were excluded for various reasons, 149 were randomly assigned to KMC (almost exclusive skin-to-skin care after stabilization), and 136 to CMC (warm room or incubator care). There were three deaths in each group and no difference in the incidence of severe disease. Hypothermia was significantly less common in KMC infants in Merida (13.5 vs 31.5 episodes/100 infants/d) and overall (10.8 vs 14.6). Exclusive breastfeeding at discharge was more common in KMC infants in Merida (80% vs 16%) and overall (88% vs 70%). KMC infants had a higher mean daily weight gain (21.3 g vs 17.7 g) and were discharged earlier (13.4 vs 16.3 d after enrolment). KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment. Mothers expressed a clear preference for KMC and health workers found it safe and convenient. KMC was cheaper than CMC in terms of salaries (US$ 11,788 vs US$ 29,888) and other running costs (US$ 7501 vs US$ 9876). This study confirms that hospital KMC for stabilized LBWI 1000-1999 g is at least as effective and safe as CMC, and shows that it is feasible in different settings, acceptable to mothers of different cultures, and less expensive. Where exclusive breastfeeding is uncommon among LBWI, KMC may bring about an increase in its prevalence and duration, with consequent benefits for health and growth. For hospitals in low-income countries KMC may represent an appropriate use of scarce resources.

SMS text message reminders to improve infant vaccination coverage in Guatemala: A pilot randomized controlled trial.

PubMed

Domek, Gretchen J; Contreras-Roldan, Ingrid L; O'Leary, Sean T; Bull, Sheana; Furniss, Anna; Kempe, Allison; Asturias, Edwin J

2016-05-05

Patient reminder systems are an evidence-based way to improve childhood vaccination rates but are difficult to implement in low- and middle-income countries (LMICs). Short Message Service (SMS) texts may offer a potential low-cost solution, especially in LMICs where mobile phones are becoming more ubiquitous. To determine if an SMS-based vaccination reminder system aimed at improving completion of the infant primary immunization series is feasible and acceptable in Guatemala. A pilot randomized controlled trial was conducted at two public health clinics in Guatemala City. Infants aged 8-14 weeks presenting for the first dose of the primary immunization series were enrolled in March-April 2013. Participants randomized into the intervention received three SMS reminders one week before the second and third dose. A follow-up acceptability survey was administered to both groups. The participation rate was 86.8% (321/370); 8 did not own a cell phone and 12 could not use SMS. 96.9% of intervention parents were sent at least one SMS reminder prior to visit 2 and 96.3% prior to visit 3. Both intervention and usual care participants had high rates of vaccine and visit completion, with a non-statistically significant higher percentage of children in the intervention completing both visit 2 (95.0% vs. 90.1%, p=.12) and visit 3 (84.4% vs. 80.7%, p=.69). More intervention vs. usual care parents agreed that SMS reminders would be helpful for remembering appointments (p<.0001), agreed to being interested in receiving future SMS reminders (p<.0001), and said that they would be willing to pay for future SMS reminders (p=.01). This proof of concept evaluation showed that a new application of SMS technology is feasible to implement in a LMIC with high user satisfaction. Larger studies with modifications in the SMS system are needed to determine effectiveness (Clinical Trial Registry NCT01663636). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon

PubMed Central

Casapía, Martín; Aguilar, Eder; Silva, Hermánn; Montresor, Antonio; Rahme, Elham; Fraser, William D.; Marquis, Grace S.; Vercruysse, Jozef; Allen, Lindsay H.; Blouin, Brittany; Razuri, Hugo; Pezo, Lidsky

2017-01-01

Background Nutritional interventions targeting the critical growth and development period before two years of age can have the greatest impact on health trajectories over the life course. Compelling evidence has demonstrated that interventions investing in maternal health in the first 1000 days of life are beneficial for both mothers and their children. One such potential intervention is deworming integrated into maternal postpartum care in areas where soil-transmitted helminth (STH) infections are endemic. Methodology/Principal Findings From February to August 2014, 1010 mother-infant pairs were recruited into a trial aimed at assessing the effectiveness of maternal postpartum deworming on infant and maternal health outcomes. Following delivery, mothers were randomly assigned to receive either single-dose 400 mg albendazole or placebo. Participants were followed-up at 1 and 6 months postpartum. There was no statistically significant difference in mean weight gain between infants in the experimental and control groups (mean difference: -0.02; 95% CI: -0.1, 0.08) at 6 months of age. Further, deworming had no effect on measured infant morbidity indicators. However, ad hoc analyses restricted to mothers who tested positive for STHs at baseline suggest that infants of mothers in the experimental group had greater mean length gain in cm (mean difference: 0.8; 95% CI: 0.1, 1.4) and length-for-age z-score (mean difference: 0.5; 95% CI: 0.2, 0.8) at 6 months of age. Conclusions/Significance In a study population composed of both STH-infected and uninfected mothers, maternal postpartum deworming was insufficient to impact infant growth and morbidity indicators up to 6 months postpartum. Among STH-infected mothers, however, important improvements in infant length gain and length-for-age were observed. The benefits of maternal postpartum deworming should be further investigated in study populations having higher overall prevalences and intensities of STH infections and, in

A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon.

PubMed

Mofid, Layla S; Casapía, Martín; Aguilar, Eder; Silva, Hermánn; Montresor, Antonio; Rahme, Elham; Fraser, William D; Marquis, Grace S; Vercruysse, Jozef; Allen, Lindsay H; Blouin, Brittany; Razuri, Hugo; Pezo, Lidsky; Gyorkos, Theresa W

2017-01-01

Nutritional interventions targeting the critical growth and development period before two years of age can have the greatest impact on health trajectories over the life course. Compelling evidence has demonstrated that interventions investing in maternal health in the first 1000 days of life are beneficial for both mothers and their children. One such potential intervention is deworming integrated into maternal postpartum care in areas where soil-transmitted helminth (STH) infections are endemic. From February to August 2014, 1010 mother-infant pairs were recruited into a trial aimed at assessing the effectiveness of maternal postpartum deworming on infant and maternal health outcomes. Following delivery, mothers were randomly assigned to receive either single-dose 400 mg albendazole or placebo. Participants were followed-up at 1 and 6 months postpartum. There was no statistically significant difference in mean weight gain between infants in the experimental and control groups (mean difference: -0.02; 95% CI: -0.1, 0.08) at 6 months of age. Further, deworming had no effect on measured infant morbidity indicators. However, ad hoc analyses restricted to mothers who tested positive for STHs at baseline suggest that infants of mothers in the experimental group had greater mean length gain in cm (mean difference: 0.8; 95% CI: 0.1, 1.4) and length-for-age z-score (mean difference: 0.5; 95% CI: 0.2, 0.8) at 6 months of age. In a study population composed of both STH-infected and uninfected mothers, maternal postpartum deworming was insufficient to impact infant growth and morbidity indicators up to 6 months postpartum. Among STH-infected mothers, however, important improvements in infant length gain and length-for-age were observed. The benefits of maternal postpartum deworming should be further investigated in study populations having higher overall prevalences and intensities of STH infections and, in particular, where whipworm and hookworm infections are of public

[Tolerance and adequacy of a 100% lactose infant formula. A controlled randomized double-blind study].

PubMed

Girardet, J-P; Fournier, V; Bakhache, P; Beck, L; Kempf, C; Lachambre, E

2012-07-01

Lactose has beneficial nutritional effects in infancy, particularly on calcium retention and on Bifidobacterium colon microflora development. The objective of this controlled, prospective, randomized double-blind study was to assess the adequacy and safety of an infant formula containing only lactose as carbohydrate, as compared to a usual formula. Healthy non-breast-fed infants aged under 7 days were randomized to be fed exclusively with a conventional formula containing lactose (9.6 g/100 kcal) and maltodextrin (1.6 g/100 kcal) or the isocaloric-isoprotein study formula containing 100% lactose (11.2 g/100 kcal) for 120 days. Primary outcome was daily weight gain at D0 and D120. Weight, length, body mass index, formula consumption, tolerance, and safety were assessed monthly. The non-inferiority of the study formula was rejected if the difference in weight gain was higher than 2.5 g/day in the control group. One hundred and seventy-eight infants were enrolled. Mean daily weight gain in the study group differed by 0.71 g/day (95% CI: -2.23; 0.82) indicating the non-inferiority of the study formula. Growth was normal and similar in the two groups, but formula intake was decreased in the study group, leading to a decrease in energy and protein intakes. Tolerance was good and adverse events did not differ between the two groups. The 100% lactose study infant formula was safe and non-inferior to a conventional formula in ensuring normal growth during the first 4 months of life. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

The effect of in-hospital developmental care on neonatal morbidity, growth and development of preterm Taiwanese infants: a randomized controlled trial.

PubMed

Chen, Li-Chiou; Wu, Ying-Chin; Hsieh, Wu-Shiun; Hsu, Chyong-Hsin; Leng, Chi-Hon; Chen, Wei J; Chiu, Nan-Chang; Lee, Wang-Tso; Yang, Ming Chin; Fang, Li-Jung; Hsu, Hui-Chin; Jeng, Suh-Fang

2013-05-01

Intervention studies of developmental care for preterm infants in Western societies have shown early but unsustainable effects on child outcomes, however only a limited of studies have examined if developmental care interventions produce similar effects in Eastern cultural contexts. To examine the effectiveness of in-hospital developmental care on neonatal morbidity, growth and development of preterm infants with very low birth weight (VLBW; birth weight<1500 g) in Taiwan. One hundred and seventy-eight VLBW preterm infants were randomly assigned to the clinical trial during hospitalization at three hospitals in Taiwan; the control group received five sessions of standard child-focused developmental care and the intervention group received five sessions of child- and parent-focused developmental care. Sixty-two normal term infants were also included as a comparison group. Infants were examined for morbidity, growth and developmental outcomes at term age. At study entry, more infants in the intervention group were twins or multiples than those in the control group (29% vs. 16%, p=0.05). After adjusting for birth set, the intervention group had lower incidences of stage II-III retinopathy (odds ratio [OR]=0.34 [95% confidence interval (CI): 0.15-0.79]; p=0.01) and feeding desaturation (OR=0.32 [95% CI: 0.10-1.00]; p=0.05) and had greater daily weight gains (difference=2.0 g/day [95% CI: 0-4.0 g/day]; p=0.05) as compared with the control group. However, the intervention and control groups did not differ in any of the neurodevelopmental measures. In-hospital developmental care has short-term benefits for Taiwanese VLBW preterm infants in reducing the risk of retinopathy and feeding desaturation as well as in enhancing weight gains at term age. Copyright © 2012 Elsevier Ltd. All rights reserved.

Docosahexaenoic Acid and Bronchopulmonary Dysplasia in Preterm Infants.

PubMed

Collins, Carmel T; Makrides, Maria; McPhee, Andrew J; Sullivan, Thomas R; Davis, Peter G; Thio, Marta; Simmer, Karen; Rajadurai, Victor S; Travadi, Javeed; Berry, Mary J; Liley, Helen G; Opie, Gillian F; Tan, Kenneth; Lui, Kei; Morris, Scott A; Stack, Jacqueline; Stark, Michael J; Chua, Mei-Chien; Jayagobi, Pooja A; Holberton, James; Bolisetty, Srinivas; Callander, Ian R; Harris, Deborah L; Gibson, Robert A

2017-03-30

Studies in animals and in humans have suggested that docosahexaenoic acid (DHA), an n-3 long-chain polyunsaturated fatty acid, might reduce the risk of bronchopulmonary dysplasia, but appropriately designed trials are lacking. We randomly assigned 1273 infants born before 29 weeks of gestation (stratified according to sex, gestational age [<27 weeks or 27 to <29 weeks], and center) within 3 days after their first enteral feeding to receive either an enteral emulsion providing DHA at a dose of 60 mg per kilogram of body weight per day or a control (soy) emulsion without DHA until 36 weeks of postmenstrual age. The primary outcome was bronchopulmonary dysplasia, defined on a physiological basis (with the use of oxygen-saturation monitoring in selected infants), at 36 weeks of postmenstrual age or discharge home, whichever occurred first. A total of 1205 infants survived to the primary outcome assessment. Of the 592 infants assigned to the DHA group, 291 (49.1% by multiple imputation) were classified as having physiological bronchopulmonary dysplasia, as compared with 269 (43.9%) of the 613 infants assigned to the control group (relative risk adjusted for randomization strata, 1.13; 95% confidence interval [CI], 1.02 to 1.25; P=0.02). The composite outcome of physiological bronchopulmonary dysplasia or death before 36 weeks of postmenstrual age occurred in 52.3% of the infants in the DHA group and in 46.4% of the infants in the control group (adjusted relative risk, 1.11; 95% CI, 1.00 to 1.23; P=0.045). There were no significant differences between the two groups in the rates of death or any other neonatal illnesses. Bronchopulmonary dysplasia based on a clinical definition occurred in 53.2% of the infants in the DHA group and in 49.7% of the infants in the control group (P=0.06). Enteral DHA supplementation at a dose of 60 mg per kilogram per day did not result in a lower risk of physiological bronchopulmonary dysplasia than a control emulsion among preterm infants

Transfusion of cell saver salvaged blood in neonates and infants undergoing open heart surgery significantly reduces RBC and coagulant product transfusions and donor exposures: results of a prospective, randomized, clinical trial.

PubMed

Cholette, Jill M; Powers, Karen S; Alfieris, George M; Angona, Ronald; Henrichs, Kelly F; Masel, Debra; Swartz, Michael F; Daugherty, L Eugene; Belmont, Kevin; Blumberg, Neil

2013-02-01

To evaluate whether transfusion of cell saver salvaged, stored at the bedside for up to 24 hrs, would decrease the number of postoperative allogeneic RBC transfusions and donor exposures, and possibly improve clinical outcomes. Prospective, randomized, controlled, clinical trial. Pediatric cardiac intensive care unit. Infants weighing less than 20 kg (n = 106) presenting for cardiac surgery with cardiopulmonary bypass. Subjects were randomized to a cell saver transfusion group where cell saver blood was available for transfusion up to 24 hrs after collection, or to a control group. Cell saver subjects received cell saver blood for volume replacement and/or RBC transfusions. Control subjects received crystalloid or albumin for volume replacement and RBCs for anemia. Blood product transfusions, donor exposures, and clinical outcomes were compared between groups. Children randomized to the cell saver group had significantly fewer RBC transfusions (cell saver: 0.19 ± 0.44 vs. control: 0.75 ± 1.2; p = 0.003) and coagulant product transfusions in the first 48 hrs post-op (cell saver: 0.09 ± 0.45 vs. control: 0.62 ± 1.4; p = 0.013), and significantly fewer donor exposures (cell saver: 0.60 ± 1.4 vs. control: 2.3 ± 4.8; p = 0.019). This difference persisted over the first week post-op, but did not reach statistical significance (cell saver: 0.64 ± 1.24 vs. control: 1.1 ± 1.4; p = 0.07). There were no significant clinical outcome differences. Cell saver blood can be safely stored at the bedside for immediate transfusion for 24 hrs after collection. Administration of cell saver blood significantly reduces the number of RBC and coagulant product transfusions and donor exposures in the immediate postoperative period. Reduction of blood product transfusions has the potential to reduce transfusion-associated complications and decrease postoperative morbidity. Larger studies are needed to determine whether this transfusion strategy will improve clinical outcomes.

Can typical US home visits affect infant attachment? Preliminary findings from a randomized trial of Healthy Families Durham.

PubMed

Berlin, Lisa J; Martoccio, Tiffany L; Appleyard Carmody, Karen; Goodman, W Benjamin; O'Donnell, Karen; Williams, Janis; Murphy, Robert A; Dodge, Kenneth A

2017-12-01

US government-funded early home visiting services are expanding significantly. The most widely implemented home visiting models target at-risk new mothers and their infants. Such home visiting programs typically aim to support infant-parent relationships; yet, such programs' effects on infant attachment quality per se are as yet untested. Given these programs' aims, and the crucial role of early attachments in human development, it is important to understand attachment processes in home visited families. The current, preliminary study examined 94 high-risk mother-infant dyads participating in a randomized evaluation of the Healthy Families Durham (HFD) home visiting program. We tested (a) infant attachment security and disorganization as predictors of toddler behavior problems and (b) program effects on attachment security and disorganization. We found that (a) infant attachment disorganization (but not security) predicted toddler behavior problems and (b) participation in HFD did not significantly affect infant attachment security or disorganization. Findings are discussed in terms of the potential for attachment-specific interventions to enhance the typical array of home visiting services.

A randomized trial to investigate the effects of pre-natal and infant nutritional supplementation on infant immune development in rural Gambia: the ENID trial: Early Nutrition and Immune Development.

PubMed

Moore, Sophie E; Fulford, Anthony Jc; Darboe, Momodou K; Jobarteh, Modou Lamin; Jarjou, Landing M; Prentice, Andrew M

2012-10-11

Recent observational research indicates that immune development may be programmed by nutritional exposures early in life. Such findings require replication from trials specifically designed to assess the impact of nutritional intervention during pregnancy on infant immune development. The current trial seeks to establish: (a) which combination of protein-energy (PE) and multiple-micronutrient (MMN) supplements would be most effective; and (b) the most critical periods for intervention in pregnancy and infancy, for optimal immune development in infancy. The ENID Trial is a 2 x 2 x 2 factorial randomized, partially blind trial to assess whether nutritional supplementation to pregnant women (from < 20 weeks gestation to term) and their infants (from 6 to 12 months of age) can enhance infant immune development. Eligible pregnant women from the West Kiang region of The Gambia (pregnancy dated by ultrasound examination) are randomized on entry to 4 intervention groups (Iron-folate (FeFol = standard care), multiple micronutrients (MMN), protein-energy (PE), PE + MMN). Women are visited at home weekly for supplement administration and morbidity assessment and seen at MRC Keneba at 20 and 30 weeks gestation for a detailed antenatal examination, including ultrasound. At delivery, cord blood and placental samples are collected, with detailed infant anthropometry collected within 72 hours. Infants are visited weekly thereafter for a morbidity questionnaire. From 6 to 12 months of age, infants are further randomized to a lipid-based nutritional supplement, with or without additional MMN. The primary outcome measures of this study are thymic development during infancy, and antibody response to vaccination. Measures of cellular markers of immunity will be made in a selected sub-cohort. Subsidiary studies to the main trial will additionally assess the impact of supplementation on infant growth and development to 24 months of age. The proposed trial is designed to test whether

Mothers' different styles of involvement in preterm infant pain care.

PubMed

Axelin, Anna; Lehtonen, Liisa; Pelander, Tiina; Salanterä, Sanna

2010-01-01

To describe and understand how mothers utilize the opportunity to actively participate in their preterm infants' pain care using facilitated tucking by parents (FTP). Descriptive and exploratory study with postintervention interview. Finnish level III Neonatal Intensive Care Unit (NICU). Twenty-three mothers who had preterm infants born at gestational ages of 32 to 34 weeks. The parents (N=45) of 29 preterm infants were taught to use FTP. In addition, all nurses in the NICU (N=76) received the same education to support the parents' use of FTP. After 2 to 4 weeks of FTP use, the mothers (n=23) were interviewed using the Clinical Interview for Parents of High-Risk Infants with additional questions related to the infants' pain care. The interviews were analyzed inductively with cross-case analysis and deductively with a previously developed coding scheme. Facilitated tucking by parents was perceived positively and was used by all participating mothers. Three different styles of involvement in preterm infants' pain care with FTP were identified. They formed a continuum from external to random and finally to internalized involvement. In external involvement, the pain care with FTP was triggered by outside factors such as nurses, whereas in random and internalized involvement the motivation emerged from a parent. Mothers with external involvement thought that any person could apply the FTP. In random involvement, mothers were mainly absent during painful procedures, although they saw themselves as the best caregivers. In internalized involvement, the responsibility for infant pain care was shared within the family. Mothers' NICU-related stress and maternal attachment were associated with this variation. This study showed that mothers' are willing to actively participate in their preterm infants' pain care. However, the participation is unique according to mother and her experiences before and during NICU admission. Nurses need to consider these differences in mothers

Practical application of kangaroo mother care in preterm infants: clinical characteristics and safety of kangaroo mother care.

PubMed

Park, Hyun-kyung; Choi, Byeong Seon; Lee, Seung Jin; Son, In-A; Seol, In-Joon; Lee, Hyun Ju

2014-03-01

To determine the clinical characteristics and safety of kangaroo mother care (KMC) according to the gestational age (GA) or postmenstrual age (PMA). We conducted a prospective clinical study in 31 infants between 25 and 32 weeks' GA. The subjects were categorized into two groups (25-28 weeks' and 29-32 weeks' GA groups) to compare the clinical characteristics associated with KMC. Heart rate, respiratory rate, oxygen saturation, blood pressure and body temperature (BT) were longitudinally assessed for 60 min with respect to the PMA group (29-32 weeks' and 33-36 weeks' PMA groups). The authors analyzed 70 sessions with 31 infants (25-32 weeks' GA, birth weight 760-1740 g, 29-36 weeks' PMA). All infants had statistically significant higher temperatures during KMC than before KMC within clinically acceptable limits (P<0.001). We found a significantly lower variation of BT in the 25-28 weeks' GA group compared with the 29-32 weeks' GA group at 33-36 weeks' PMA, suggesting accelerated skin maturation in more premature infants (P<0.001). Our intermittent KMC was a safe and feasible method for preterm infants. Notably, at the same PMA, preterm infants in the lower at-birth GA group showed an advanced maturation of thermoregulation compared with those in the higher GA group.

How well do clinical pain assessment tools reflect pain in infants?

PubMed

Slater, Rebeccah; Cantarella, Anne; Franck, Linda; Meek, Judith; Fitzgerald, Maria

2008-06-24

Pain in infancy is poorly understood, and medical staff often have difficulty assessing whether an infant is in pain. Current pain assessment tools rely on behavioural and physiological measures, such as change in facial expression, which may not accurately reflect pain experience. Our ability to measure cortical pain responses in young infants gives us the first opportunity to evaluate pain assessment tools with respect to the sensory input and establish whether the resultant pain scores reflect cortical pain processing. Cortical haemodynamic activity was measured in infants, aged 25-43 wk postmenstrual, using near-infrared spectroscopy following a clinically required heel lance and compared to the magnitude of the premature infant pain profile (PIPP) score in the same infant to the same stimulus (n = 12, 33 test occasions). Overall, there was good correlation between the PIPP score and the level of cortical activity (regression coefficient = 0.72, 95% confidence interval [CI] limits 0.32-1.11, p = 0.001; correlation coefficient = 0.57). Of the different PIPP components, facial expression correlated best with cortical activity (regression coefficient = 1.26, 95% CI limits 0.84-1.67, p < 0.0001; correlation coefficient = 0.74) (n = 12, 33 test occasions). Cortical pain responses were still recorded in some infants who did not display a change in facial expression. While painful stimulation generally evokes parallel cortical and behavioural responses in infants, pain may be processed at the cortical level without producing detectable behavioural changes. As a result, an infant with a low pain score based on behavioural assessment tools alone may not be pain free.

Effect of nutritional supplementation of breastfeeding HIV positive mothers on maternal and child health: findings from a randomized controlled clinical trial

PubMed Central

2011-01-01

Background It has been well established that breastfeeding is beneficial for child health, however there has been debate regarding the effect of lactation on maternal health in the presence of HIV infection and the need for nutritional supplementation in HIV positive lactating mothers. Aims To assess the effect of nutritional supplementation to HIV infected lactating mothers on nutritional and health status of mothers and their infants. Methods A randomized controlled clinical trial to study the impact of nutritional supplementation on breastfeeding mothers. Measurements included anthropometry; body composition indicators; CD4 count, haemoglobin and albumin; as well as incidence rates of opportunistic infections; depression and quality of life scores. Infant measurements included anthropometry, development and rates of infections. Results The supplement made no significant impact on any maternal or infant outcomes. However in the small group of mothers with low BMI, the intake of supplement was significantly associated with preventing loss of lean body mass (1.32 kg vs. 3.17 kg; p = 0.026). There was no significant impact of supplementation on the infants. Conclusions A 50 g daily nutritional supplement to breastfeeding mothers had no or limited effect on mother and child health outcomes. Clinical trial registration ISRCTN68128332 (http://www.controlled-trials.com/ISRCTN68128332) PMID:22192583

Clinical assessment of infant colour at delivery

PubMed Central

O'Donnell, Colm P F; Kamlin, C Omar F; Davis, Peter G; Carlin, John B; Morley, Colin J

2007-01-01

Objective Use of video recordings of newborn infants to determine: (1) if clinicians agreed whether infants were pink; and (2) the pulse oximeter oxygen saturation (Spo2) at which infants first looked pink. Methods Selected clips from video recordings of infants taken immediately after delivery were shown to medical and nursing staff. The infants received varying degrees of resuscitation (including none) and were monitored with pulse oximetry. The oximeter readings were obscured to observers but known to the investigators. A timer was visible and the sound was inaudible. The observers were asked to indicate whether each infant was pink at the beginning, became pink during the clip, or was never pink. If adjudged to turn pink during the clip, observers recorded the time this occurred and the corresponding Spo2 was determined. Results 27 clinicians assessed videos of 20 infants (mean (SD) gestation 31(4) weeks). One infant (5%) was perceived to be pink by all observers. The number of clinicians who thought each of the remaining 19 infants were never pink varied from 1 (4%) to 22 (81%). Observers determined the 10 infants with a maximum Spo2 ⩾95% never pink on 17% (46/270) of occasions. The Spo2 at which individual infants were perceived to turn pink varied from 10% to 100%. Conclusion Among clinicians observing the same videos there was disagreement about whether newborn infants looked pink with wide variation in the Spo2 when they were considered to become pink. PMID:17613535

The effect of integration of HIV care and treatment into antenatal care clinics on mother-to-child HIV transmission and maternal outcomes in Nyanza, Kenya: results from the SHAIP cluster randomized controlled trial

PubMed Central

Washington, Sierra; Owuor, Kevin; Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Shade, Starley B.; Bukusi, Elizabeth A.; Ackers, Marta L.; Cohen, Craig R.

2015-01-01

Background Many HIV-infected pregnant women identified during antenatal care do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. Methods We performed a cluster-randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, PMTCT, and HIV care delivered in the ANC clinic; n=6 intervention facilities), or standard ANC services (including PMTCT and referral to a separate clinic for HIV care; n=6 control facilities). Results There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was twelve month follow up data for 256/611 (41.8%) women, and postpartum data for only 325/1172 (28%) women. By 9 months of age, 382/568 (67.3%) infants at intervention sites and 338/594 (57.0%) at control sites had tested for HIV (OR 1.45, 95% CI 0.71-2.82); 7.3% of infants tested HIV-positive at intervention sites compared to 8.0% of infants at control sites (OR 0.89, 95% CI 0.56-1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1 %, OR 0.83, 95% CI 0.41 - 1.68). Conclusions Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk HIV transmission to infants and did not appear to affect short-term maternal health outcomes. PMID:25886930

Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial.

PubMed

Ashley, Claude; Johnston, William H; Harris, Cheryl L; Stolz, Suzanne I; Wampler, Jennifer L; Berseth, Carol Lynn

2012-06-07

To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow's milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone. In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow's milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) (n = 142) or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139) or 4 g/L of GOS alone (GOS; n = 138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study. There were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P < 0.05). The overall incidence of medically-confirmed adverse events was similar among groups

Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial.

PubMed

Nankabirwa, Victoria; Tumwine, James K; Namugga, Olive; Tylleskär, Thorkild; Ndeezi, Grace; Robberstad, Bjarne; Netea, Mihai G; Sommerfelt, Halvor

2017-03-31

Bacillus Calmette-Guérin (BCG) vaccination may have nonspecific effects, i.e., effects on childhood morbidity and mortality that go beyond its effect on the risk of childhood tuberculosis (TB). Though the available scientific literature is mostly from observational studies, and is fraught with controversy, BCG vaccination at birth may protect infants in high-mortality populations against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy may modify immune responses to non-TB antigens and potentially enhance immunity, potentially also against tuberculosis (TB). It is unclear whether BCG vaccination very early in life offers adequate protection against TB and other infections among HIV-1-exposed children because even those who remain uninfected with HIV-1 show signs of impaired immunocompetence early in infancy. This study will compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV-1-exposed infants. This is an individually randomized controlled trial in 2200 HIV-1-exposed infants. The intervention is BCG vaccination within 24 h of birth while the comparator is BCG given at 14 weeks of age. The study co-primary outcomes are severe illness in the first 14 weeks of life, and production of tumor necrosis factor, interleukin (IL)-1β, IL-6 and interferon-γ in response to mycobacterial and nonmycobacterial antigens. The study is being conducted in three health centers in Uganda. A well-timed BCG vaccination could have important nonspecific effects in HIV-1-exposed infants. This trial could inform the development of appropriate timing of BCG vaccination for HIV-1-exposed infants. ClinicalTrials.gov, identifier: NCT02606526 . Registered on 12 November 2015.

Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

PubMed

Relton, Clare; Strong, Mark; Thomas, Kate J; Whelan, Barbara; Walters, Stephen J; Burrows, Julia; Scott, Elaine; Viksveen, Petter; Johnson, Maxine; Baston, Helen; Fox-Rushby, Julia; Anokye, Nana; Umney, Darren; Renfrew, Mary J

2018-02-05

Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government

Monitoring Doppler patterns and clinical parameters may predict feeding tolerance in intrauterine growth-restricted infants.

PubMed

Bozzetti, Valentina; Paterlini, Giuseppe; Gazzolo, Diego; Van Bel, Frank; Visser, Gerard H A; Roncaglia, Nadia; Tagliabue, Paolo E

2013-11-01

To detect predictors of feeding tolerance in intrauterine growth restriction (IUGR) infants with or without brain-sparing effect (BS). We conducted a case-control study in 70 IUGR infants (35 IUGR with BS, matched for gestational age with 35 IUGR infants with no BS). BS was classified as pulsatility index (PI) ratio [umbilical artery (UAPI) to middle cerebral artery (MCAPI) (U/C ratio)] > 1. Clinical parameters of feeding tolerance - days to achieve full enteral feeding (FEF) - were compared between the IUGR with BS and IUGR without BS infants. Age at the start of minimal enteral feeding (MEF) was analysed. Achievement of FEF was significantly shorter in IUGR infants without BS than in IUGR with BS. IUGR with BS started MEF later than IUGR without BS infants. Significant correlation of MEF and FEF with UA PI, U/C ratio and CRIB score was found. Multiple linear regression analysis showed significant correlations with CRIB score and caffeine administration (MEF only), and sepsis (FEF only) and U/C ratio (for both). Impaired gut function can be early detected by monitoring Doppler patterns and clinical parameters. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media.

PubMed

Noel, Gary J; Blumer, Jeffrey L; Pichichero, Michael E; Hedrick, James A; Schwartz, Richard H; Balis, Dainius A; Melkote, Rama; Bagchi, Partha; Arguedas, Adriano

2008-06-01

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections. In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM. A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent. Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

Healthy late preterm infants and supplementary artificial milk feeds: effects on breast feeding and associated clinical parameters.

PubMed

Mattsson, Elisabet; Funkquist, Eva-Lotta; Wickström, Maria; Nyqvist, Kerstin H; Volgsten, Helena

2015-04-01

to compare the influence of supplementary artificial milk feeds on breast feeding and certain clinical parameters among healthy late preterm infants given regular supplementary artificial milk feeds versus being exclusively breast fed from birth. a comparative study using quantitative methods. Data were collected via a parental diary and medical records. parents of 77 late preterm infants (34 5/7-36 6/7 weeks), whose mothers intended to breast feed, completed a diary during the infants׳ hospital stay. infants who received regular supplementary artificial milk feeds experienced a longer delay before initiation of breast feeding, were breast fed less frequently and had longer hospital stays than infants exclusively breast fed from birth. Exclusively breast-fed infants had a greater weight loss than infants with regular artificial milk supplementation. A majority of the mothers (65%) with an infant prescribed artificial milk never expressed their milk and among the mothers who used a breast-pump, milk expression commenced late (10-84 hours after birth). At discharge, all infants were breast fed to some extent, 43% were exclusively breast fed. clinical practice and routines influence the initiation of breast feeding among late preterm infants and may act as barriers to the mothers׳ establishment of exclusive breast feeding. Copyright © 2015 Elsevier Ltd. All rights reserved.

Reference values of amino acids and of common clinical chemistry in plasma of healthy infants aged 1 and 4 months.

PubMed

Haschke-Becher, Elisabeth; Kainz, Alexander; Bachmann, Claude

2016-01-01

To compare plasma levels of amino acids and clinical chemistry parameters in healthy infants at 1 and 4 months of age and to establish corresponding reference limits. Data of three multicenter studies assessing the safety of new infant formulas were used. During these studies infants of both age-groups were either breast-fed or received formulas of low or high protein content. All samples were analyzed centrally in the same accredited laboratory. Plasma was collected from 521 infants in total, 157 boys and 135 girls aged 1 month and 121 boys and 108 girls aged 4 months. At the age of 1 month, 62 infants had received exclusively breast milk, 198 exclusively formula, and 27 both; in the 4-months age group corresponding numbers were 49, 158 and 18, respectively; for 9 infants, diet was unknown. Concentrations of most amino acids and clinical chemistry parameters differed significantly between both ages. Regardless of age, most plasma amino acid levels were comparable or lower in breast-fed than in formula-fed infants whereas at 1 month of age most clinical chemistry parameters were higher. While in breast-fed infants the plasma urea concentration decreased over 4 months of age, it increased in formula-fed infants. There were significant differences between infants fed a low and high protein formula. At both ages, high protein formulas resulted in significantly higher threonine, 2-aminobutyrate, and urea concentrations. For clinical use, age- and diet specific reference limits in infants are warranted.

Kangaroo mother care for low birth weight infants: a randomized controlled trial.

PubMed

Suman, Rao P N; Udani, Rekha; Nanavati, Ruchi

2008-01-01

To compare the effect of Kangaroo mother care (KMC) and conventional methods of care (CMC) on growth in LBW babies (> 2000 g). Randomized controlled trial. Level III NICU of a teaching institution in western India. 206 neonates with birth weight < 2000 g. The subjects were randomized into two groups: the intervention group (KMC-103) received Kangaroo mother care. The control group (CMC: 103) received conventional care. Growth, as measured by average daily weight gain and by other anthropometrical parameters at 40 weeks postmenstrual age in preterm babies and at 2500 g in term SGA infants was assessed. The KMC babies had better average weight gain per day (KMC: 23.99 g vs CMC: 15.58 g, P< 0.0001). The weekly increments in head circumference (KMC: 0.75 cm vs CMC: 0.49 cm, P = 0.02) and length (KMC: 0.99 cm vs CMC: 0.7 cm, P = 0.008) were higher in the KMC group. A significantly higher number of babies in the CMC group suffered from hypothermia, hypoglycemia, and sepsis. There was no effect on time to discharge. More KMC babies were exclusively breastfed at the end of the study (98% vs 76%). KMC was acceptable to most mothers and families at home. Kangaroo mother care improves growth and reduces morbidities in low birth weight infants. It is simple, acceptable to mothers and can be continued at home.

Impact of Malaria at the End of Pregnancy on Infant Mortality and Morbidity

PubMed Central

Sigauque, Betuel; Sanz, Sergi; Maixenchs, María; Ordi, Jaume; Aponte, John J; Mabunda, Samuel; Alonso, Pedro L; Menéndez, Clara

2011-01-01

Background. There is some consensus that malaria in pregnancy may negatively affect infant's mortality and malaria morbidity, but there is less evidence concerning the factors involved. Methods. A total of 1030 Mozambican pregnant women were enrolled in a randomized, placebo-controlled trial of intermittent preventive treatment with sulfadoxine-pyrimethamine, and their infants were followed up throughout infancy. Overall mortality and malaria morbidity rates were recorded. The association of maternal and fetal risk factors with infant mortality and malaria morbidity was assessed. Results. There were 58 infant deaths among 997 live-born infants. The risk of dying during infancy was increased among infants born to women with acute placental infection (odds ratio [OR], 5.08 [95% confidence interval (CI), 1.77–14.53)], parasitemia in cord blood (OR, 19.31 [95% CI, 4.44–84.02]), low birth weight (OR, 2.82 [95% CI, 1.27–6.28]) or prematurity (OR, 3.19 [95% CI, 1.14–8.95]). Infants born to women who had clinical malaria during pregnancy (OR, 1.96 [95% CI, 1.13–3.41]) or acute placental infection (OR, 4.63 [95% CI, 2.10–10.24]) had an increased risk of clinical malaria during infancy. Conclusions. Malaria infection at the end of pregnancy and maternal clinical malaria negatively impact survival and malaria morbidity in infancy. Effective clinical management and prevention of malaria in pregnancy may improve infant's health and survival. PMID:21199881

Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: A Systematic Review

PubMed Central

2013-01-01

Background There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objective of this study was to compare the methodological quality, outcomes of food industry sponsored trials versus non industry sponsored trials, with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula. Methods A comprehensive search was conducted to identify published and unpublished randomized clinical trials (RCTs). Cochrane methodology was used to assess the risk of bias of included RCTs in the following domains: 1) sequence generation; 2) allocation concealment; 3) blinding; 4) incomplete outcome data; 5) selective outcome reporting; and 6) other bias. Clinical outcomes and authors’ conclusions were reported in frequencies and percentages. The association between source of funding, risk of bias, clinical outcomes and conclusions were assessed using Pearson’s Chi-square test and the Fisher’s exact test. A p-value < 0.05 was statistically significant. Results Sixty seven completed and 3 on-going RCTs were included. Forty (59.7%) were funded by food industry, 11 (16.4%) by non-industry entities and 16 (23.9%) did not specify source of funding. Several risk of bias domains, especially sequence generation, allocation concealment and blinding, were not adequately reported. There was no significant association between the source of funding and sequence generation, allocation concealment, blinding and selective reporting, majority of reported clinical outcomes or authors’ conclusions. On the other hand, source of funding was significantly associated with the domains of incomplete outcome data, free of other bias domains as well as reported antibiotic use and conclusions on weight gain. Conclusion In RCTs on infants fed infant formula containing probiotics, prebiotics or synbiotics, the source of funding did not

Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial.

PubMed

Shah, Sanket D; Dereddy, Narendra; Jones, Tamekia L; Dhanireddy, Ramasubbareddy; Talati, Ajay J

2016-07-01

To compare the effect of initiating human milk fortification at 2 different feeding volumes on feeding intolerance and the time to reach full feeding volume. Very low birth weight infants (n = 100) were prospectively randomized to early fortification (EF) (beginning at a feeding volume of 20 mL/kg/d) or delayed fortification (at a feeding volume of 100 mL/kg/d). We employed a standardized feeding protocol and parenteral nutrition guidelines for the nutritional management of all study infants. The median days to reach full feeding volumes were equivalent in the 2 groups (20 vs 20, P = .45). No significant difference was observed in the total number of episodes of feeding intolerance (58 vs 57). Two cases of necrotizing enterocolitis (Bell stage ≥2) and deaths occurred in each group. Median daily protein intake (g/kg/d) was higher in EF group in week 1 (3.3 [3.2, 3.5] vs 3.1 [2.9, 3.3], P < .001), week 2 (3.6 [3.5, 3.8] vs 3.2 [2.9, 3.4], P < .001), and week 3 (3.7 [3.4, 3.9] vs 3.5 [2.8, 3.8], P = .006). Cumulative protein intake (g/kg) in the first 4 weeks of life was higher in EF group (98.6 [93.8, 104] vs 89.6 [84.2, 96.4], P < .001). Very early human milk fortification may improve early protein intake in very low birth weight infants without increasing frequencies of adverse events. ClinicalTrials.gov: NCT01988792. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical features and prevalence of gastroesophageal reflux disease in infants attending a pediatric gastroenterology reference service.

PubMed

Koda, Yu Kar Ling; Ozaki, Marcos J; Murasca, Kelly; Vidolin, Eliana

2010-01-01

In infants, it is not always easy to distinguish between pathological and physiological gastroesophageal reflux based only on clinical criteria. In Brazil, studies about gastroesophageal reflux disease in infants are few and are even rare those that used prolonged esophageal pH monitoring for its evaluation. To describe the clinical features of gastroesophageal reflux disease and to determine its prevalence in infants with gastroesophageal reflux attending a tertiary Pediatric Gastroenterology Service and submitted to esophageal pH monitoring for investigation. Descriptive study in 307 infants in whom esophageal pH monitoring (Mark III Digitrapper, Synectics Medical AB, Sweden) was performed during the period December, 1998-December, 2008. The clinical features studied were age group (1-12 months and 13-24 months), and clinical manifestations that motivated the indication of pH monitoring. One hundred twenty-four (40.4%) were female and 183 (59.6%) male with mean age 12.2 +/- 6.2 months (1-23 months). The prevalence of gastroesophageal reflux disease was 18.2% (56/307). One hundred forty-eight (48.2%) were 1-12 months old and 159 (51.8%), 13-24 months. No significant difference was found between the prevalence of these two age groups (P = 0.3006). Gastroesophageal reflux disease was more frequent in those with digestive manifestations (24.2%), crisis of cyanosis/apnea (23.8%) and mixed manifestations (21.5%). Respiratory manifestations were the most frequent indication (39.1%) of pH monitoring. However, the prevalence of gastroesophageal reflux disease was lower (12.5%) in this group compared with in those with digestive manifestations (P = 0.0574), crisis of cyanosis/apnea (P = 0.0882) and mixed manifestations (P = 0.1377). All infants that presented clinical manifestations as crisis of cyanosis/apnea and abnormal pH-metry were < 3 months of age. In our Service, the prevalence of gastroesophageal reflux disease associated with acid reflux in infants revealed

Infant intersubjectivity: research, theory, and clinical applications.

PubMed

Trevarthen, C; Aitken, K J

2001-01-01

rhythms of infant behaviour, especially in communication, and neonates' extraordinary capacities for reactive and evocative imitation. The correct functioning of this integrated neural motivating system is found to be essential to the development of both the infant's purposeful consciousness and his or her ability to cooperate with other persons' actions and interests, and to learn from them. The relevance of infants' inherent intersubjectivity to major child mental health issues is highlighted by examining selected areas of clinical concern. We review recent findings on postnatal depression, prematurity, autism, ADHD, specific language impairments, and central auditory processing deficits, and comment on the efficacy of interventions that aim to support intrinsic motives for intersubjective communication when these are not developing normally.

The impact of dialogic book-sharing training on infant language and attention: a randomized controlled trial in a deprived South African community

PubMed Central

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J.

2015-01-01

Background Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings. Accordingly, we aimed to establish the impact on child language and attention of providing training in dialogic booksharing to carers of infants in an impoverished South African community. Methods We conducted a randomized controlled trial in Khayelitsha, an informal settlement in South Africa. Mothers of infants aged between 14 and 16 months were recruited and randomized to either eight weeks of manualized training in dialogic book-sharing or a no-intervention control group. Independent assessments were made of infant language and attention at baseline and following training. The trial was registered (ISRCTN39953901). Results Ninety one carer-infant dyads were recruited and randomized to the intervention group (n = 49) or the control group (n = 42), 82 (90%) of whom were available for follow-up assessments. On a standardized carer report of infant vocabulary, compared to those in the control group, carers who received the intervention reported a significantly greater increase in the number of words understood by their infants as well as a larger increase in the number of words that their infant understood and could vocalize. Intervention group children also showed substantially greater gains on a measure of sustained attention. Conclusions In line with evidence from HICs, a dialogic book-sharing programme delivered to an impoverished South African sample was shown to be of considerable benefit to the development of child language and focussed attention. The training programme, which is simple and inexpensive to deliver, has the potential to benefit child cognitive development in LMIC contexts where such development is commonly

Higher protein intake increases cardiac function parameters in healthy children: metabolic programming by infant nutrition-secondary analysis from a clinical trial.

PubMed

Collell, Rosa; Closa-Monasterolo, Ricardo; Ferré, Natalia; Luque, Veronica; Koletzko, Berthold; Grote, Veit; Janas, Roman; Verduci, Elvira; Escribano, Joaquín

2016-06-01

Protein intake may modulate cardiac structure and function in pathological conditions, but there is a lack of knowledge on potential effects in healthy infants. Secondary analysis of an ongoing randomized clinical trial comparing two groups of infants receiving a higher (HP) or lower (LP) protein content formula in the first year of life, and compared with an observational group of breastfed (BF) infants. Growth and dietary intake were assessed periodically from birth to 2 y. Insulin-like growth factor 1 (IGF-1) axis parameters were analyzed at 6 mo in a blood sample. At 2 y, cardiac mass and function were assessed by echocardiography. HP infants (n = 50) showed a higher BMI z-score at 2 y compared with LP (n = 47) or BF (n = 44). Cardiac function parameters were increased in the HP group compared with the LP and were directly related to the protein intake during the first 6 mo of life. Moreover, there was an increase in free IGF-1 in the HP group at 6 mo. A moderate increase in protein supply during the first year of life is associated with higher cardiac function parameters at 2 y. IGF-1 axis modifications may, at least in part, underlie these effects.

Short-term impact of a randomized multifaceted intervention for wheezing infants in low-income families.

PubMed

Klinnert, Mary D; Liu, Andrew H; Pearson, Marcella R; Ellison, Misoo C; Budhiraja, Nisha; Robinson, Joann L

2005-01-01

To present an interim analysis of the effect of a home-based intervention with low-income caregivers of wheezing infants at risk for childhood asthma on mediating variables. Infants aged 9 to 24 months with 3 or more physician-documented wheezing episodes were randomly assigned to environmental support intervention (ES) (n = 90) or control (n = 91) groups. Nurse home visitors intervened for 1 year to decrease allergen and environmental tobacco smoke exposure and improve symptom perception and management. Assessments at baseline and 12 months included allergens in house dust, infant urinary cotinine levels, caregivers' symptom reports, quality of life, illness management, and quality of caregiving. Medical records were coded for hospitalizations, emergency department visits, and corticosteroid bursts. Within the ES group, cockroach allergen levels were significantly reduced and there was a trend toward reduction in dog dander levels. Among infants with detectable urinary cotinine, levels were significantly reduced in the ES group. Caregiver psychological resources modified the impact, and low-resource ES caregivers were the most strongly affected. Asthma knowledge and provider collaboration improved significantly in the ES group. Neither reports of infant symptoms nor emergency department visits or hospitalizations showed positive intervention effects. Number of corticosteroid bursts for infants was significantly higher for the ES group. The Childhood Asthma Prevention Study intervention was effective in reducing several environmental exposures and improving illness management. However, even with an intensive home-based intervention, we failed to reduce respiratory symptoms or medical use in the ES group relative to the control group, illustrating the difficulty of changing the course of early asthma development among low-income infants.

One Extra Gram of Protein to Preterm Infants From Birth to 1800 g: A Single-Blinded Randomized Clinical Trial.

PubMed

Bellagamba, Maria Paola; Carmenati, Elisabetta; D'Ascenzo, Rita; Malatesta, Michela; Spagnoli, Cristina; Biagetti, Chiara; Burattini, Ilaria; Carnielli, Virgilio P

2016-06-01

The aim of the study was to evaluate the effect on growth and neurodevelopment of increasing amino acid (AA) during parenteral nutrition and protein intake during enteral nutrition in extremely low birth-weight infants starting from birth to day of reaching 1800 g body weight. We randomized preterm infants with birth weight 500 to 1249 g either to a high AA/protein intake (HiP [high protein]: parenteral nutrition = 3.5 AA, enteral nutrition = 4.6 protein g · kg · day) or to a standard of care group (StP [standard protein]: parenteral nutrition = 2.5 AA, enteral nutrition = 3.6 protein g · kg · day). The primary outcome was weight gain from birth to 1800 g. TWO:: hundred twenty-six patients were screened, 164 completed the study and were analyzed (82 StP and 82 HiP). Cumulative AA/protein intake from birth to 1800 g was 178 ± 42 versus 223 ± 45 g/kg in the StP versus HiP group respectively, P < 0.0001.Blood urea was higher in HiP than in StP group both during parenteral and enteral nutrition (P = 0.004).Weight gain from birth to 1800 g was 12.3 ± 1.6 in StP and 12.6 ± 1.7 g · kg · day in HiP group (P = 0.294). We found no difference in any growth parameters neither during hospital stay nor at 2 years corrected age. Bayley III score at 24 months corrected age was 93.8 ± 12.9 in StP group and 94.0 ± 13.9 in the HiP group, P = 0.92. Increasing AA/protein intake both during parenteral and enteral nutrition does not improve growth and neurodevelopment of small preterm infants 500 to 1249 g birth weight.

Food allergy in infants and children: clinical evaluation and management.

PubMed

Levy, Y; Kornbroth, B; Ofer, I; Garty, B Z; Danon, Y L

1994-12-01

A total of 122 infants and children up to age 17 (69 males and 53 females) who were referred for food allergy to the Pediatric Allergy and Clinical Immunology Unit were evaluated by complete history, emphasizing the implicated foods, clinical presentation and involvement of various organ systems, physical examination, and prick skin tests to food allergens. Fourteen infants with a history of egg white allergy and positive skin tests to egg white also underwent skin tests (prick and intradermal in 1:100 dilution) to measles-mumps-rubella (MMR) vaccine; 35 children under 3 years old had 41 oral challenges with the suspected foods; and 9 children over 3 years old had 12 oral challenges with the suspected foods. We found that cow milk/humanized milk formula, egg white, soybean, and peanut are the main allergenic foods in the pediatric population. Thirteen children had 13 positive oral challenges: 12 to cow milk/humanized milk formula and one to egg white. Symptoms reproduced by oral challenges included urticarial and erythematous rash, conjunctival itching, angioedema, abdominal pain, vomiting, diarrhea, and rhinorrhea. No anaphylactic shock was reported. Negative skin test has an excellent predictive accuracy for negative oral challenge with the suspected food in children > 3 years old. The negative predictive accuracy of cow milk skin test in children < 3 years was 73%. Positive skin test is not a good predictor of a clinical reaction to food. Oral food challenge performed cautiously in a medical setting is the "gold standard" for diagnosis. MMR vaccine can be safely administered to infants with egg white allergy after skin tests with the vaccine are performed.

Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial

PubMed Central

Gajdos, Vincent; Katsahian, Sandrine; Beydon, Nicole; Abadie, Véronique; de Pontual, Loïc; Larrar, Sophie; Epaud, Ralph; Chevallier, Bertrand; Bailleux, Sylvain; Mollet-Boudjemline, Alix; Bouyer, Jean; Chevret, Sylvie; Labrune, Philippe

2010-01-01

Background Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis. Methods and Findings We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n = 246) or nasal suction (NS, control group, n = 250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97–2.73) for the control group and 2.02 days (95% CI 1.96–2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]  = 1.09, 95% CI 0.91–1.31, p = 0.33). No treatment by age interaction was found (p = 0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]  = 10.2, 95% CI 1.3–78.8, p = 0.005 and RR  = 5.4, 95% CI 1.6–18

Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial

PubMed Central

2011-01-01

Background Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis. Discussion This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants. Trial registration number Netherlands Trial Register (NTR): NTR2768 PMID:22070744

The "Golden Age" of Probiotics: A Systematic Review and Meta-Analysis of Randomized and Observational Studies in Preterm Infants.

PubMed

Dermyshi, Elda; Wang, Yizhong; Yan, Chongbin; Hong, Wenchao; Qiu, Gang; Gong, Xiaohui; Zhang, Ting

2017-01-01

Over the last few years, probiotics have been one of the most studied interventions in neonatal medicine. The aim of this work was to analyse all studies (randomized controlled trials, RCTs, and observational studies) assessing the use of probiotics in very low birth weight (VLBW) preterm infants. A systematic literature search was conducted using PubMed, Embase, Cochrane Library, and Web of Science. The data from RCTs and observational studies were pooled and analysed separately. RCTs and observational studies that enrolled VLBW infants with enteral administration of probiotics were considered. Extracted study data included probiotic characteristics and at least 1 clinical outcome (necrotizing enterocolitis [NEC], late-onset sepsis or all-cause mortality). Forty-four studies were eligible for our review: 30 RCTs and 14 observational studies. Severe NEC rates (stage II or more) and all-cause mortality were reduced among the probiotic groups in both the RCTs (RR 0.57, 95% CI 0.47-0.70, and RR 0.77, 95% CI 0.65-0.92, respectively) and the observational studies (RR 0.51, 95% CI 0.37-0.70, and RR 0.71, 95% CI 0.62-0.81, respectively). Furthermore, there was a 12% reduction in the risk of sepsis in RCTs and a 19% reduction in observational studies. The meta-analysis of observational studies showed a reduction in the risk of NEC in extremely low birth weight infants. However, this was not statistically significant. This meta-analysis of RCT and observational studies found that the use of probiotics was beneficial for the prevention of severe NEC, late-onset sepsis, and all-cause mortality in VLBW infants. © 2017 S. Karger AG, Basel.

Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.

PubMed

Lemyre, Brigitte; Fusch, Christoph; Schmölzer, Georg M; Rouvinez Bouali, Nicole; Reddy, Deepti; Barrowman, Nicholas; Huneault-Purney, Nicole; Lacaze-Masmonteil, Thierry

2017-01-01

To compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. Randomized, partially-blinded, multicenter trial. Infants <32 weeks needing surfactant before 48 hours were randomly assigned to receive poractant alfa or bovine lipid extract surfactant. The primary outcome was being alive and extubated at 48 hours post-randomization. Secondary outcomes included need for re-dosing, duration of respiratory support and oxygen, bronchopulmonary dysplasia, mortality and complications during administration. Three centers recruited 87 infants (mean 26.7 weeks and 906 grams) at a mean age of 5.9 hours, between March 2013 and December 2015. 21/42 (50%) were alive and extubated at 48 hours in the poractant alfa group vs 26/45 (57.8%) in the bovine lipid extract surfactant group; adjusted OR 0.76 (95% CI 0.30-1.93) (p = 0.56). No differences were observed in the need to re-dose. Duration of oxygen support (41.5 vs 62 days; adjusted OR 1.69 95% CI 1.02-2.80; p = 0.04) was reduced in infants who received poractant alfa. We observed a trend in bronchopulmonary dysplasia among survivors (51.5% vs 72.1%; adjusted OR 0.35 95%CI 0.12-1.04; p = 0.06) favoring poractant alfa. Twelve infants died before discharge, 9 in the poractant alfa group and 3 in the bovine lung extract group. Severe airway obstruction following administration was observed in 0 (poractant alfa) and 5 (bovine lipid extract surfactant) infants (adjusted OR 0.09 95%CI <0.01-1.27; p = 0.07). No statistically significant difference was observed in the proportion of infants alive and extubated within 48h between the two study groups. Poractant alfa may be more beneficial and associated with fewer complications than bovine lipid extract surfactant. However, we observed a trend towards higher mortality in the poractant alfa group. Larger studies are needed to determine whether observed possible benefits translate in shorter hospital admissions, or other long term benefits and

Bach music in preterm infants: no 'Mozart effect' on resting energy expenditure.

PubMed

Keidar, H Rosenfeld; Mandel, D; Mimouni, F B; Lubetzky, R

2014-02-01

To study whether Johan Sebastian Bach music has a lowering effect on resting energy expenditure (REE) similar to that of Wolfgang Amadeus Mozart music. Prospective, randomized clinical trial with cross-over in 12 healthy, appropriate weights for gestational age (GA), gavage fed, metabolically stable, preterm infants. Infants were randomized to a 30-min period of either Mozart or Bach music or no music over 3 consecutive days. REE was measured every minute by indirect calorimetry. Three REE measurements were performed in each of 12 infants at age 20±15.8 days. Mean GA was 30.17±2.44 weeks and mean birthweight was 1246±239 g. REE was similar during the first 10-min of all three randomization periods. During the next 10-min period, infants exposed to music by Mozart had a trend toward lower REE than when not exposed to music. This trend became significant during the third 10-min period. In contrast, music by Bach or no music did not affect significantly REE during the whole study. On average, the effect size of Mozart music upon REE was a reduction of 7.7% from baseline. Mozart music significantly lowers REE in preterm infants, whereas Bach music has no similar effect. We speculate that 'Mozart effect' must be taken into account when incorporating music in the therapy of preterm infants, as not all types of music may have similar effects upon REE and growth.

Clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing open heart surgery.

PubMed

Campbell, Miranda; Rabbidge, Bridgette; Ziviani, Jenny; Sakzewski, Leanne

2017-08-01

Assessing the neurodevelopmental status of infants with congenital heart disease before surgery provides a means of identifying those at heightened risk of developmental delay. This study aimed to investigate factors impacting clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing early open heart surgery. Infants who underwent open heart surgery prior to 4 months of age participated in this cross-sectional study. The Test of Infant Motor Performance and Prechtl's Assessment of General Movements were undertaken on infants pre-operatively. When assessments could not be undertaken, reasons were ascribed to either infant or environmental circumstances. Demographic data and Aristotle scores were compared between groups of infants who did or did not undergo assessment. Binary logistic regression was used to explore associations. A total of 60 infants participated in the study. Median gestational age was 38.78 weeks (interquartile range: 36.93-39.72). Of these infants, 37 (62%) were unable to undergo pre-operative assessment. Twenty-four (40%) could not complete assessment due to infant-related factors and 13 (22%) due to environmental-related factors. For every point increase in the Aristotle Patient-Adjusted Complexity score, the infants likelihood of being unable to undergo assessment increased by 35% (odds ratio: 0.35; 95% confidence interval: 1.03-1.77, P = 0.03). Over half of the infants undergoing open heart surgery were unable to complete pre-operative neurodevelopmental assessment. The primary reason for this was infant-related medical instability. Findings suggest further research is warranted to investigate whether the Aristotle Patient-Adjusted Complexity score might serve as an indicator to inform developmental surveillance with this medically fragile cohort. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

Building Competency in Infant Mental Health Practice: The Edith Cowan University Pregnancy to Parenthood Clinic

ERIC Educational Resources Information Center

Matacz, Rochelle; Priddis, Lynn

2016-01-01

This article describes a unique Australian infant mental health (IMH) service for families from pregnancy through to early parenthood (0-3 years) and training center for postgraduate clinical psychology students. The Australian Association for Infant Mental Health Incorporated, West Australia Branch (AAIMHI WA) "Competency Guidelines"®…

Effect of Therapeutic Hypothermia Initiated After 6 Hours of Age on Death or Disability Among Newborns With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial.

PubMed

Laptook, Abbot R; Shankaran, Seetha; Tyson, Jon E; Munoz, Breda; Bell, Edward F; Goldberg, Ronald N; Parikh, Nehal A; Ambalavanan, Namasivayam; Pedroza, Claudia; Pappas, Athina; Das, Abhik; Chaudhary, Aasma S; Ehrenkranz, Richard A; Hensman, Angelita M; Van Meurs, Krisa P; Chalak, Lina F; Khan, Amir M; Hamrick, Shannon E G; Sokol, Gregory M; Walsh, Michele C; Poindexter, Brenda B; Faix, Roger G; Watterberg, Kristi L; Frantz, Ivan D; Guillet, Ronnie; Devaskar, Uday; Truog, William E; Chock, Valerie Y; Wyckoff, Myra H; McGowan, Elisabeth C; Carlton, David P; Harmon, Heidi M; Brumbaugh, Jane E; Cotten, C Michael; Sánchez, Pablo J; Hibbs, Anna Maria; Higgins, Rosemary D

2017-10-24

Hypothermia initiated at less than 6 hours after birth reduces death or disability for infants with hypoxic-ischemic encephalopathy at 36 weeks' or later gestation. To our knowledge, hypothermia trials have not been performed in infants presenting after 6 hours. To estimate the probability that hypothermia initiated at 6 to 24 hours after birth reduces the risk of death or disability at 18 months among infants with hypoxic-ischemic encephalopathy. A randomized clinical trial was conducted between April 2008 and June 2016 among infants at 36 weeks' or later gestation with moderate or severe hypoxic-ischemic encephalopathy enrolled at 6 to 24 hours after birth. Twenty-one US Neonatal Research Network centers participated. Bayesian analyses were prespecified given the anticipated limited sample size. Targeted esophageal temperature was used in 168 infants. Eighty-three hypothermic infants were maintained at 33.5°C (acceptable range, 33°C-34°C) for 96 hours and then rewarmed. Eighty-five noncooled infants were maintained at 37.0°C (acceptable range, 36.5°C-37.3°C). The composite of death or disability (moderate or severe) at 18 to 22 months adjusted for level of encephalopathy and age at randomization. Hypothermic and noncooled infants were term (mean [SD], 39 [2] and 39 [1] weeks' gestation, respectively), and 47 of 83 (57%) and 55 of 85 (65%) were male, respectively. Both groups were acidemic at birth, predominantly transferred to the treating center with moderate encephalopathy, and were randomized at a mean (SD) of 16 (5) and 15 (5) hours for hypothermic and noncooled groups, respectively. The primary outcome occurred in 19 of 78 hypothermic infants (24.4%) and 22 of 79 noncooled infants (27.9%) (absolute difference, 3.5%; 95% CI, -1% to 17%). Bayesian analysis using a neutral prior indicated a 76% posterior probability of reduced death or disability with hypothermia relative to the noncooled group (adjusted posterior risk ratio, 0.86; 95% credible interval

Clinical utility of the Structured Observation of Motor Performance in Infants within the child health services

PubMed Central

Persson, Kristina; Sonnander, Karin; Magnusson, Margaretha; Sarkadi, Anna; Lucas, Steven

2017-01-01

Aim This study aimed to evaluate the clinical utility of the Structured Observation of Motor Performance in Infants (SOMP-I) when used by nurses in routine child healthcare by analyzing the nurses’ SOMP-I assessments and the actions taken when motor problems were suspected. Method Infants from three child health centers in Uppsala County, Sweden, were consecutively enrolled in a longitudinal study. The 242 infants were assessed using SOMP-I by the nurse responsible for the infant as part of the regular well-child visits at as close to 2, 4, 6 and 10 months of age as possible. The nurses noted actions taken such as giving advice, scheduling an extra follow-up or referring the infant to specialized care. The infants’ motor development was reassessed at 18 months of age through review of medical records or parental report. Results The assessments of level of motor development at 2 and 10 months showed a distribution corresponding to the percentile distribution of the SOMP-I method. Fewer infants than expected were assessed as delayed at 4 and 6 months or deficient in quality at all assessment ages. When an infant was assessed as delayed in level or deficient in quality, the likelihood of the nurse taking actions increased. This increased further if both delay and quality deficit were found at the same assessment or if one or both were found at repeated assessments. The reassessment of the motor development at 18 months did not reveal any missed infants with major motor impairments. Interpretation The use of SOMP-I appears to demonstrate favorable clinical utility in routine child healthcare as tested here. Child health nurses can assess early motor performance using this standardized assessment method, and using the method appears to support them the clinical decision-making. PMID:28723929

Introduction of Complementary Foods to Infants.

PubMed

West, Christina

2017-01-01

While earlier food allergy prevention strategies implemented avoidance of allergenic foods in infancy, the current paradigm is shifting from avoidance to controlled exposure. This review focuses on the outcome of recent randomized controlled trials, which have examined the early introduction of allergenic foods for allergy prevention, and discusses the implementation of results in clinical practice. In infants at high risk of allergic disease, there is now direct evidence that regular early peanut consumption will reduce the prevalence of peanut allergy, compared to avoidance. Many international infant feeding guidelines already recommend complementary foods, including allergenic foods, to be introduced from 4 to 6 months of age irrespective of family history risk. Interim guidelines from 10 International Pediatric Allergy Associations state that healthcare providers should recommend the introduction of peanut-containing products into the diets of infants at high risk of allergic disease in countries where peanut allergy is prevalent. Direct translation of the results obtained from a cohort of high-risk infants to the general population has proved difficult, and issues regarding feasibility, safety, and cost-effectiveness have been raised. Five randomized placebo-controlled trials have assessed the effects of early egg exposure in infancy with varying results. In a recent comprehensive meta-analysis, there was moderate-certainty evidence that early versus late introduction of egg was associated with a reduced egg allergy risk. Although promising, optimal timing, doses, and if the feeding regimen should be stratified according to infant allergy risk remain to be determined. The single study that assessed introduction of multiple foods from 3 months whilst breastfeeding compared with exclusive breastfeeding until 6 months of age showed no reduction in food allergy prevalence. Future research should aim at optimizing infant feeding regimens and support a tolerogenic

Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial.

PubMed

Rongsen-Chandola, Temsunaro; Winje, Brita Askeland; Goyal, Nidhi; Rathore, Sudeep Singh; Mahesh, Madhu; Ranjan, Rajat; Arya, Alok; Rafiqi, Farhana Afzal; Bhandari, Nita; Strand, Tor A

2014-06-28

Neutralizing antibodies in breast milk may adversely influence the immune response to live oral vaccines. Withholding breastfeeding around the time of vaccine administration has been suggested for improving vaccine performance. However, we do not know whether mothers find withholding breastfeeding around the time of vaccination acceptable and how they perceive this recommendation. In a clinical study designed to examine predictors of poor immune response to rotavirus vaccine in infants in India, Rotarix® was administered to infants at 6 and 10 weeks with other childhood vaccines. For the study, 400 mother-infant pairs were randomized into two groups in a 1:1 ratio. Mothers were either recommended to withhold breastfeeding or were encouraged to breastfeed half an hour before and after administration of Rotarix®. The mother-infant pairs were observed and the breastfeeding intervals were recorded during this period. Mothers were administered a questionnaire about their perception of the intervention after the infants received the second dose of Rotarix®. Almost 98% (391/400) of the infants received both doses of Rotarix®. Adherence to the recommendations was high in both groups. All mothers in the group who were asked to withhold breastfeeding did so, except one who breastfed her infant before the recommended time after the first dose of Rotarix®. Of the mothers, 4% (7/195) reported that the recommendation to withhold breastfeeding was difficult to follow. All mothers in this group reported that they would withhold breastfeeding at the time of vaccination if they were asked to by a health-care provider. Only one mother responded that withholding breastfeeding would be a reason for not giving rotavirus vaccine to her infant. Withholding breastfeeding half an hour before and after vaccination appears to be acceptable to mothers in this setting. If withholding breastfeeding produces an improvement in the performance of the vaccine, it could be used to increase the

Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial

PubMed Central

2014-01-01

Background Neutralizing antibodies in breast milk may adversely influence the immune response to live oral vaccines. Withholding breastfeeding around the time of vaccine administration has been suggested for improving vaccine performance. However, we do not know whether mothers find withholding breastfeeding around the time of vaccination acceptable and how they perceive this recommendation. Methods In a clinical study designed to examine predictors of poor immune response to rotavirus vaccine in infants in India, Rotarix® was administered to infants at 6 and 10 weeks with other childhood vaccines. For the study, 400 mother–infant pairs were randomized into two groups in a 1:1 ratio. Mothers were either recommended to withhold breastfeeding or were encouraged to breastfeed half an hour before and after administration of Rotarix®. The mother–infant pairs were observed and the breastfeeding intervals were recorded during this period. Mothers were administered a questionnaire about their perception of the intervention after the infants received the second dose of Rotarix®. Results Almost 98% (391/400) of the infants received both doses of Rotarix®. Adherence to the recommendations was high in both groups. All mothers in the group who were asked to withhold breastfeeding did so, except one who breastfed her infant before the recommended time after the first dose of Rotarix®. Of the mothers, 4% (7/195) reported that the recommendation to withhold breastfeeding was difficult to follow. All mothers in this group reported that they would withhold breastfeeding at the time of vaccination if they were asked to by a health-care provider. Only one mother responded that withholding breastfeeding would be a reason for not giving rotavirus vaccine to her infant. Conclusions Withholding breastfeeding half an hour before and after vaccination appears to be acceptable to mothers in this setting. If withholding breastfeeding produces an improvement in the performance of the

The Clinical and Biochemical Predictors of Bone Mass in Preterm Infants.

PubMed

Czech-Kowalska, Justyna; Czekuc-Kryskiewicz, Edyta; Pludowski, Pawel; Zaniuk, Katarzyna; Jaworski, Maciej; Łuba, Anna; Grzybowska, Karolina; Piłat, Krystyna; Dobrzanska, Anna

2016-01-01

Metabolic bone disease of prematurity still occurs in preterm infants, although a significant improvement in neonatal care has been observed in recent decades. Dual-energy X-ray absorptiometry (DXA) is the precise technique for assessing bone mineral content (BMC) in preterm infants, but is not widely available. To investigate the clinical and biochemical parameters, including bone metabolism markers as potential predictors of BMC, in preterm infants up to 3 months corrected age (CA). Ca-P homeostasis, iPTH, 25-hydroxyvitamin D, osteocalcin, N-terminal propeptide, cross-linked C-telopeptide and amino-terminal pro C-type natriuretic peptide and the DXA scans were prospectively performed in 184 preterm infants (≤ 34 weeks' gestation) between term age and 3 mo CA. Lower bone mass was defined as BMC below or equal to respective median value for the whole study group, rounded to the nearest whole number. The appropriate quality DXA scans were available for 160 infants (87%) examined at term and for 130 (71%) tested at 3 mo CA. Higher iPTH level was the only independent predictor of lower BMC at term, whereas lower BMC at 3 mo CA was associated both with lower urinary phosphate excretion and higher serum osteocalcin level. ROC analysis showed that iPTH >43.6 pg/mL provided 40% sensitivity and 88% specificity in identification of preterm infants with lower BMC at term. In turn, urinary phosphate excretion (TRP>97% or UP/Cr ≤0.74 mg/mg) and serum osteocalcin >172 ng/mL provided 40% sensitivity and 93% specificity in identification of infants with decreased BMC at 3 mo CA. Serum iPTH might to be a simple predictor of reduced BMC in preterm infants at term age, but urinary phosphate excretion and serum osteocalcin might predict reduced BMC at 3 mo CA. These results represent a promising diagnostic tool based on simple, widely available biochemical measurements for bone mass assessment in preterm infants.

A qualitative study of clinical reasoning in physiotherapy with preterm infants and their parents: Action and interaction.

PubMed

Håkstad, Ragnhild B; Obstfelder, Aud; Øberg, Gunn Kristin

2018-09-01

Physiotherapists (PTs) in primary health care provide services to preterm infants and their parents after hospital discharge. The service should be collaborative and individualized to meet the family's needs. In this study, we analyze pediatric PTs' collaborative work in the clinical setting and investigate the PTs' emerging clinical reasoning (CR) in interaction with the infant and parent(s). The study is based on observations of 20 physical therapy sessions and 20 interviews with PTs. We performed a systematic content analysis informed by enactive theory regarding the interactions and co-creation of meaning. CR emerged in reciprocity with the PTs' interaction with the infant and parent(s). Based on the sensitivity to the infant's motor abilities and signs of engagement as well as the parents' need of support and education, the PTs individualized and reasoned about their therapeutic approach. This interactional CR was vulnerable: infant disengagement, parent expectations, and PT preoccupations could obfuscate interactions and hamper CR. Through mutuality and engagement with the infant and parent(s), the PTs allow the autonomy of interaction to emerge and shape the translation of CR into successful therapeutic actions and learning together with the infant and parent(s).

454 pyrosequencing analysis on faecal samples from a randomized DBPC trial of colicky infants treated with Lactobacillus reuteri DSM 17938.

PubMed

Roos, Stefan; Dicksved, Johan; Tarasco, Valentina; Locatelli, Emanuela; Ricceri, Fulvio; Grandin, Ulf; Savino, Francesco

2013-01-01

To analyze the global microbial composition, using large-scale DNA sequencing of 16 S rRNA genes, in faecal samples from colicky infants given L. reuteri DSM 17938 or placebo. Twenty-nine colicky infants (age 10-60 days) were enrolled and randomly assigned to receive either Lactobacillus reuteri (10(8) cfu) or a placebo once daily for 21 days. Responders were defined as subjects with a decrease of 50% in daily crying time at day 21 compared with the starting point. The microbiota of faecal samples from day 1 and 21 were analyzed using 454 pyrosequencing. The primers: Bakt_341F and Bakt_805R, complemented with 454 adapters and sample specific barcodes were used for PCR amplification of the 16 S rRNA genes. The structure of the data was explored by using permutational multivariate analysis of variance and effects of different variables were visualized with ordination analysis. The infants' faecal microbiota were composed of Proteobacteria, Firmicutes, Actinobacteria and Bacteroidetes as the four main phyla. The composition of the microbiota in infants with colic had very high inter-individual variability with Firmicutes/Bacteroidetes ratios varying from 4000 to 0.025. On an individual basis, the microbiota was, however, relatively stable over time. Treatment with L. reuteri DSM 17938 did not change the global composition of the microbiota, but when comparing responders with non-responders the group responders had an increased relative abundance of the phyla Bacteroidetes and genus Bacteroides at day 21 compared with day 0. Furthermore, the phyla composition of the infants at day 21 could be divided into three enterotype groups, dominated by Firmicutes, Bacteroidetes, and Actinobacteria, respectively. L. reuteri DSM 17938 did not affect the global composition of the microbiota. However, the increase of Bacteroidetes in the responder infants indicated that a decrease in colicky symptoms was linked to changes of the microbiota. ClinicalTrials.gov NCT00893711.

Beneficial effects of zinc supplementation on head circumference of Nepalese infants and toddlers: a randomized controlled trial.

PubMed

Surkan, P J; Shankar, M; Katz, J; Siegel, E H; Leclerq, S C; Khatry, S K; Stoltzfus, R J; Tielsch, J M

2012-07-01

To assess the effects of micronutrient supplementation on head circumference of rural Nepali infants and children. We used a randomized controlled trial to assess the effects of micronutrient supplementation on head circumference in 569 rural Nepali infants and children aged 4-17 months. Children were randomized to: (1) zinc, (2) iron-folic acid, (3) zinc plus iron-folic acid or (4) a placebo group. Data on head circumference were collected during five visits at ∼3 month intervals over the course of a year. We calculated change in head circumference in treatment groups receiving zinc and iron comparing the first and fifth visits as well as used generalized estimating equations (GEE) to take advantage of data from all points in time. Models were adjusted for covariates unbalanced in the randomization and for baseline head circumference. Estimating differences in head circumference between baseline and visit 5, children in the zinc treatment group showed smaller decreases in head circumference z-score compared with placebo (adjusted β=0.13, 95% confidence interval (CI): 0.03 to 0.23). Using GEE, zinc treatment was associated with 0.11 (95% CI: 0.05 to 0.17) decrease in the rate of decline in head circumference z-score across visits as compared with placebo. Iron-folic acid supplementation was not associated with head circumference z-scores when comparing visits 1 with 5 or including data across all visits in adjusted models. Our results suggest that zinc supplementation confers a beneficial effect on the rate of head growth in Nepali infants.

Maternal choline supplementation during the third trimester of pregnancy improves infant information processing speed: a randomized, double-blind, controlled feeding study.

PubMed

Caudill, Marie A; Strupp, Barbara J; Muscalu, Laura; Nevins, Julie E H; Canfield, Richard L

2018-04-01

Rodent studies demonstrate that supplementing the maternal diet with choline during pregnancy produces life-long cognitive benefits for the offspring. In contrast, the two experimental studies examining cognitive effects of maternal choline supplementation in humans produced inconsistent results, perhaps because of poor participant adherence and/or uncontrolled variation in intake of choline or other nutrients. We examined the effects of maternal choline supplementation during pregnancy on infant cognition, with intake of choline and other nutrients tightly controlled. Women entering their third trimester were randomized to consume, until delivery, either 480 mg choline/d ( n = 13) or 930 mg choline/d ( n = 13). Infant information processing speed and visuospatial memory were tested at 4, 7, 10, and 13 mo of age ( n = 24). Mean reaction time averaged across the four ages was significantly faster for infants born to mothers in the 930 ( vs. 480) mg choline/d group. This result indicates that maternal consumption of approximately twice the recommended amount of choline during the last trimester improves infant information processing speed. Furthermore, for the 480-mg choline/d group, there was a significant linear effect of exposure duration (infants exposed longer showed faster reaction times), suggesting that even modest increases in maternal choline intake during pregnancy may produce cognitive benefits for offspring.-Caudill, M. A., Strupp, B. J., Muscalu, L., Nevins, J. E. H., Canfield, R. L. Maternal choline supplementation during the third trimester of pregnancy improves infant information processing speed: a randomized, double-blind, controlled feeding study.

Timing of cord clamping in very preterm infants: more evidence is needed.

PubMed

Tarnow-Mordi, William O; Duley, Lelia; Field, David; Marlow, Neil; Morris, Jonathan; Newnham, John; Paneth, Nigel; Soll, Roger F; Sweet, David

2014-08-01

In December 2012, the American College of Obstetricians and Gynecologists published a Committee Opinion entitled "Timing of umbilical cord clamping after birth." It stated that "evidence exists to support delayed cord clamping in preterm infants, when feasible. The single most important benefit for preterm infants is the possibility for a nearly 50% reduction in IVH." However, the Committee Opinion added that the ideal timing of umbilical cord clamping has yet to be determined and recommended that large clinical trials be conducted in the most preterm infants. Published randomized controlled trials include <200 infants of <30 weeks' gestation, with assessments of neurodevelopmental outcome in less than one-half of the children. This is a major gap in the evidence. Without reliable data from randomized controlled trials that optimally include childhood follow-up evaluations, we will not know whether delayed cord clamping may do more overall harm than good. Ongoing trials of delayed cord clamping plan to report childhood outcomes in >2000 additional very preterm infants. Current recommendations may need to change when these results become available. Greater international collaboration could accelerate resolution of whether this promising intervention will improve disability-free survival in about 1 million infants who will be born very preterm globally each year. Copyright © 2014 Mosby, Inc. All rights reserved.

Impact of oral probiotics on neurodevelopmental outcomes in preterm infants.

PubMed

Akar, Melek; Eras, Zeynep; Oncel, Mehmet Yekta; Arayici, Sema; Guzoglu, Nilufer; Canpolat, Fuat Emre; Uras, Nurdan; Oguz, Serife Suna

2017-02-01

The aim of the study was to evaluate the neurodevelopment outcomes of very low birth weight (VLBW) preterm infants supplemented with oral probiotics for the prevention of necrotizing enterocolitis (NEC). A prospective follow-up study was performed in a cohort of VLBW preterm infants enrolled in a single center randomized controlled clinical trial to evaluate the efficacy of oral probiotics for the prevention of NEC. Cognitive and neuromotor developments were assessed by using the Bayley scales of infant development II. Sensory and neurological performance was evaluated by standard techniques. The primary outcome was neurodevelopmental impairment at 18-24 months' corrected age. A total of 400 infants completed the trial protocol. Of the 370 infants eligible for follow-up, 249 infants (124 in the probiotics group and 125 in the control group) were evaluated. There was no significant difference in any of the neurodevelopmental and sensory outcomes between the two groups. Oral probiotic given to VLBW infants to reduce the incidense and severity of NEC started with the first feed did not affect neuromotor, neurosensory and cognitive outcomes at 18-24 months' corrected age.

Early CPAP versus surfactant in extremely preterm infants.

PubMed

Finer, Neil N; Carlo, Waldemar A; Walsh, Michele C; Rich, Wade; Gantz, Marie G; Laptook, Abbot R; Yoder, Bradley A; Faix, Roger G; Das, Abhik; Poole, W Kenneth; Donovan, Edward F; Newman, Nancy S; Ambalavanan, Namasivayam; Frantz, Ivan D; Buchter, Susie; Sánchez, Pablo J; Kennedy, Kathleen A; Laroia, Nirupama; Poindexter, Brenda B; Cotten, C Michael; Van Meurs, Krisa P; Duara, Shahnaz; Narendran, Vivek; Sood, Beena G; O'Shea, T Michael; Bell, Edward F; Bhandari, Vineet; Watterberg, Kristi L; Higgins, Rosemary D

2010-05-27

There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. The results of this study support

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable

Pilot Randomized Trial of Hydrocortisone in Ventilator-Dependent Extremely Preterm Infants: Effects on Regional Brain Volumes

PubMed Central

Parikh, Nehal A.; Kennedy, Kathleen A.; Lasky, Robert E.; McDavid, Georgia E.; Tyson, Jon E.

2012-01-01

Objective To test the hypothesis that high-risk ventilator-dependent extremely low birth weight (ELBW; BW ≤1000g) infants treated with seven days of hydrocortisone will have larger total brain tissue volumes than placebo treated infants. Study design A predetermined sample size of 64 ELBW infants, between 10 to 21 days old and ventilator-dependent with a respiratory index score ≥2, were randomized to systemic hydrocortisone (17 mg/kg cumulative dose) or saline placebo. Primary outcome was total brain tissue volume. Volumetric MRI was performed at 38 weeks postmenstrual age; brain tissue regions were segmented and quantified automatically with a high degree of accuracy and nine structures were segmented manually. All analyses of regional brain volumes were adjusted by postmenstrual age at MRI scan. Results The study groups were similar at baseline and eight infants died in each arm. Unadjusted total brain tissue volume (mean±SD) in the hydrocortisone (N=23) and placebo treated infants (N=21) was 272±40.3 cm3 and 277.8±59.1 cm3, respectively (adjusted mean difference: 6.35 cm3 (95% CI: (−20.8, 32.5); P=0.64). Three of the 31 hydrocortisone treated infants and five of the 33 placebo treated infants survived without severe BPD (RR 0.62, 95% CI: 0.13, 2.66; P=0.49). No significant differences were noted in pre-specified secondary outcomes of regional structural volumes or days on respiratory support. No adverse effects of hydrocortisone were observed. Conclusions Low dose hydrocortisone in high-risk ventilator-dependent infants after a week of age had no discernible effect on regional brain volumes or pulmonary outcomes prior to NICU discharge. PMID:23140612

[Clinical efficacy of pulmonary surfactant combined with budesonide for preventing bronchopulmonary dysplasia in very low birth weight infants].

PubMed

Pan, Jing; Chen, Ming-Wu; Ni, Wen-Quan; Fang, Tao; Zhang, Hui; Chen, Ye; Pan, Jia-Hua

2017-02-01

To explore the clinical efficacy of intratracheal instillation of pulmonary surfactant (PS) combined with budesonide for preventing bronchopulmonary dysplasia (BPD) in very low birth weight (VLBW) infants. Thirty VLBW infants with gestational age <32 weeks who developed neonatal respiratory distress syndrome (NRDS) (grade III-IV) suffering from intrauterine infection were randomly assigned into a PS + budesonide group and a PS alone group. The changes were compared between the two groups in arterial blood gas indexes, oxygenation index (OI), duration of mechanical ventilation, duration of oxygen supplementation, incidence of BPD, mortality rate at 36 weeks corrected gestational age and incidences of other complications except BPD. Compared with the PS alone group, the PS+budesonide group had a lower incidence of BPD, shorter duration of mechanical ventilation and oxygen supplementation (P<0.05). On the 2nd to 6th day after treatment, the PS+budesonide group had higher pH value of arterial blood gas and OI and lower carbon dioxide partial pressure compared with the PS alone group (P<0.05). There were no significant differences in the mortality rate at 36 weeks corrected gestational age and the incidences of other complications except BPD between the two groups (P>0.05). Intratracheal instillation of PS combined with budesonide can effectively reduce the incidence of BPD in VLBW premature infants with severe NRDS.

Effect of human rotavirus vaccine on severe diarrhea in African infants.

PubMed

Madhi, Shabir A; Cunliffe, Nigel A; Steele, Duncan; Witte, Desirée; Kirsten, Mari; Louw, Cheryl; Ngwira, Bagrey; Victor, John C; Gillard, Paul H; Cheuvart, Brigitte B; Han, Htay H; Neuzil, Kathleen M

2010-01-28

Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children. We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine--the pooled vaccine group--or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale. A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group. Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (Clinical

The impact of dialogic book-sharing training on infant language and attention: a randomized controlled trial in a deprived South African community.

PubMed

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J

2015-08-01

Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings. Accordingly, we aimed to establish the impact on child language and attention of providing training in dialogic booksharing to carers of infants in an impoverished South African community. We conducted a randomized controlled trial in Khayelitsha, an informal settlement in South Africa. Mothers of infants aged between 14 and 16 months were recruited and randomized to either 8 weeks of manualized training in dialogic book-sharing or a no-intervention control group. Independent assessments were made of infant language and attention at baseline and following training. The trial was registered (ISRCTN39953901). Ninety one carer-infant dyads were recruited and randomized to the intervention group (n = 49) or the control group (n = 42), 82 (90%) of whom were available for follow-up assessments. On a standardized carer report of infant vocabulary, compared to those in the control group, carers who received the intervention reported a significantly greater increase in the number of words understood by their infants as well as a larger increase in the number of words that their infant understood and could vocalize. Intervention group children also showed substantially greater gains on a measure of sustained attention. In line with evidence from HICs, a dialogic book-sharing programme delivered to an impoverished South African sample was shown to be of considerable benefit to the development of child language and focussed attention. The training programme, which is simple and inexpensive to deliver, has the potential to benefit child cognitive development in LMIC contexts where such development is commonly compromised. © 2014 Association for Child

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

PubMed

Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

Impact of a Randomized Controlled Trial to Reduce Bedsharing on Breastfeeding Rates and Duration for African-American Infants.

PubMed

Moon, Rachel Y; Mathews, Anita; Joyner, Brandi L; Oden, Rosalind P; He, Jianping; McCarter, Robert

2017-08-01

Bedsharing is associated with both increased breastfeeding and increased risk of sudden and unexpected infant deaths. The objective was to determine impact of sleep location and counseling about sleep location on breastfeeding exclusivity and duration in African-Americans. 1194 mothers of newborns were randomized to receive messaging emphasizing either safe sleep practices to reduce SIDS risk or safe sleep practices to prevent SIDS/suffocation. Mothers completed four interviews in the 6 months after delivery. The most common sleep arrangement was roomsharing without bedsharing ("roomsharing"). Duration of any breastfeeding was 6.1 and 5.3 weeks for infants who usually bedshared or roomshared, respectively (p = 0.01). Duration of exclusive breastfeeding was 3.0 and 1.6 weeks for infants who usually bedshared or roomshared, respectively (p < 0.001). Group assignment did not affect breastfeeding duration. The most common sleep arrangement for African-American infants <6 months was roomsharing. An intervention designed to discourage bedsharing did not impact breastfeeding duration.

Randomized controlled trial of the effect of a home visiting intervention on infant cognitive development in peri-urban South Africa

PubMed Central

Murray, Lynne; Cooper, Peter; Arteche, Adriane; Stein, Alan; Tomlinson, Mark

2016-01-01

Summary Aim To determine whether, in an impoverished South African community, an intervention that benefitted infant attachment also benefitted cognitive development. Method Pregnant women were randomized to intervention (220) and no treatment control groups (229). The intervention was home-based parenting support for attachment, delivered until six months postpartum. At 18 months, infants were assessed on attachment6, and cognitive development (Bayley MDI) (127 intervention, 136 control). Infant MDI was examined in relation to intervention, socio-economic risk, antenatal depression, and infant sex and attachment. Results Overall, there was little effect of the intervention on MDI (p=.094, d=0.20), but there was an interaction between intervention and risk (p=.03, ŋp2=.02): MDI scores of infants of lower risk intervention group mothers were, on average, 4·84 points higher than those of other infants (p=.002, d=.41). Antenatal depression was not significant once intervention and risk were controlled (p= .08); there was no association between infant MDI and either sex (p =.41) or attachment (p=.56). Conclusion Parenting interventions for infant cognitive development may benefit from inclusion of specific components to support infant cognition, beyond those that support attachment, and may be most effective for infants over six months. They may need augmentation with other input where adversity is extreme. PMID:26303135

Optimal Target Range of Closed-Loop Inspired Oxygen Support in Preterm Infants: A Randomized Cross-Over Study.

PubMed

van den Heuvel, Maria Elisabeth Nicoletta; van Zanten, Henriette A; Bachman, Tom E; Te Pas, Arjan B; van Kaam, Anton H; Onland, Wes

2018-06-01

To investigate the effect of different pulse oximetry (SpO 2 ) target range settings during automated fraction of inspired oxygen control (A-FiO 2 ) on time spent within a clinically set SpO 2 alarm range in oxygen-dependent infants on noninvasive respiratory support. Forty-one preterm infants (gestational age [median] 26 weeks, age [median] 21 days) on FiO 2  >0.21 receiving noninvasive respiratory support were subjected to A-FiO 2 using 3 SpO 2 target ranges (86%-94%, 88%-92%, or 89%-91%) in random order for 24 hours each. Before switching to the next target range, SpO 2 was manually controlled for 24 hours (washout period). The primary outcome was the time spent within the clinically set alarm limits of 86%-94%. The percent time within the 86%-94% SpO 2 alarm range was similar for all 3 A-FiO 2 target ranges (74%). Time spent in hyperoxemia was not significantly different between target ranges. However, the time spent in severe hypoxemia (SpO 2  <80%) was significantly reduced during the narrowed target ranges of A-FiO 2 (88%-92%; 1.9%, 89%-91%; 1.7%) compared with the wide target range (86%-94%; 3.4%, P < .001). There were no differences between the 88%-92% and 89-91% target range. Narrowing the target range of A-FiO 2 to the desired median ±2% is effective in reducing the time spent in hypoxemia, without increasing the risk of hyperoxemia. www.trialregister.nl: NTR4368. Copyright © 2018 Elsevier Inc. All rights reserved.

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.

PubMed

Campbell, Karen J; Hesketh, Kylie D; McNaughton, Sarah A; Ball, Kylie; McCallum, Zoë; Lynch, John; Crawford, David A

2016-02-18

Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. ACTRN12611000386932. Registered 13 April 2011.

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

PubMed Central

Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2008-01-01

Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will provide important information

Run-Reversal Equilibrium for Clinical Trial Randomization

PubMed Central

Grant, William C.

2015-01-01

In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608

Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis.

PubMed

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie; Tita, Alan T N; Leveno, Kenneth J; Reddy, Uma M; Varner, Michael W; Thorp, John M; Mercer, Brian M; Dinsmoor, Mara J; Ramin, Susan M; Carpenter, Marshall W; Samuels, Philip; Sciscione, Anthony; Tolosa, Jorge E; Saade, George; Sorokin, Yoram

2018-05-23

To determine the frequency of sepsis and other adverse neonatal outcomes in women with a clinical diagnosis of chorioamnionitis. We performed a secondary analysis of a multi-center placebo-controlled trial of vitamins C/E to prevent preeclampsia in low risk nulliparous women. Clinical chorioamnionitis was defined as either the "clinical diagnosis" of chorioamnionitis or antibiotic administration during labor because of an elevated temperature or uterine tenderness in the absence of another cause. Early-onset neonatal sepsis was categorized as "suspected" or "confirmed" based on a clinical diagnosis with negative or positive blood, urine or cerebral spinal fluid cultures, respectively, within 72 h of birth. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by logistic regression. Data from 9391 mother-infant pairs were analyzed. The frequency of chorioamnionitis was 10.3%. Overall, 6.6% of the neonates were diagnosed with confirmed (0.2%) or suspected (6.4%) early-onset sepsis. Only 0.7% of infants born in the setting of chorioamnionitis had culture-proven early-onset sepsis versus 0.1% if chorioamnionitis was not present. Clinical chorioamnionitis was associated with both suspected [OR 4.01 (3.16-5.08)] and confirmed [OR 4.93 (1.65-14.74)] early-onset neonatal sepsis, a need for resuscitation within the first 30 min after birth [OR 2.10 (1.70-2.61)], respiratory distress [OR 3.14 (2.16-4.56)], 1 min Apgar score of ≤3 [OR 2.69 (2.01-3.60)] and 4-7 [OR 1.71 (1.43-2.04)] and 5 min Apgar score of 4-7 [OR 1.67 (1.17-2.37)] (vs. 8-10). Clinical chorioamnionitis is common and is associated with neonatal morbidities. However, the vast majority of exposed infants (99.3%) do not have confirmed early-onset sepsis.

Lipid profile of different infant formulas for infants

PubMed Central

Mendonça, Marcio Antonio; Araújo, Wilma Maria Coelho; Borgo, Luiz Antonio; Alencar, Ernandes de Rodrigues

2017-01-01

Situations including premature infants, or those in which there is a rejection to breastfeeding, require the use infant formulas for total or partial replacement of human milk. The objective of this study was to determine the lipid content and to identify the lipid profile of infant formulas. Samples were collected from ten different infant formulas, used as a substitute for breast milk at the Maternal and Child Hospital of Brasilia. The human milk sample consisted of a pool of samples from 10 mature milk donors at the milk bank of the University Hospital of Brasilia. The lipid content and lipid profile of the different infant formulas and human milk were analyzed. The experiment was conducted in a randomized block design, with eleven treatments and three replicates, in triplicate. The data obtained in this study indicated significant differences between infant formulas and human milk, and among the infant formulas analyzed in relation to the percentage of total lipids and the fatty acid profile, except for the fractions of linoleic acid and linolenic acid. Regarding the percentage of polyunsaturated fatty acids in relation to the total unsaturated fatty acids, only the Soy Protein Isolate-based Infant Formula (SPIIF) and Whey Protein Extensively Hydrolyzed Infant Formula (WPEHIF) resembled human milk. It was concluded that despite the observed differences, the use of infant formulas is a viable strategy for the development of infants subjected or not to specific physiological conditions. PMID:28570611

Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial.

PubMed

El-Farrash, Rania A; El Shimy, Mohammed S; El-Sakka, Abeer S; Ahmed, Manal G; Abdel-Moez, Dina G

2018-05-09

The objective of this study is to evaluate the efficacy and safety of oral paracetamol versus oral ibuprofen in the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. An interventional randomized case-control study, registered in ClinicalTrials.gov (NCT03265782), was conducted on 60 preterm infants with gestational age ≤34 weeks, postnatal age of 2-7 d and color Doppler echocardiographic evidence of hsPDA. Neonates were randomly assigned to two groups: 30 received oral ibuprofen and 30 received oral paracetamol. With failure of ductal closure, a second course of ibuprofen or paracetamol was given. The included newborns were subjected to detailed history, clinical examination, laboratory investigations that included complete blood count, renal, and liver function tests and echocardiographic evaluation. Oral paracetamol was as effective as ibuprofen for the closure of patent ductus arteriosus (PDA) with one course of treatment (p > .05). Moreover, oral paracetamol was superior to ibuprofen among neonates who needed second course of treatment with significant decrease in end diastolic flow velocity in the left pulmonary artery (0.35 ± 0.09 versus 0.19 ± 0.06, p = .014), right ventricular systolic pressure (40.50 ± 12.91 versus 20.50 ± 0.58, p = .016) and left atrium to aortic root ratio (1.23 ± 0.14 versus 1.07 ± 0.04, p = .046) when compared to ibuprofen group. Furthermore, the mean difference between pre- and post-treatment PDA size was significantly higher in the paracetamol group compared with ibuprofen group after the second course of treatment (1.07 ± 0.32 versus 0.73 ± 0.38, p = .024). Oral paracetamol was comparable with ibuprofen in terms of the rate of non-surgical ductal closure [28 (93.3%) versus 24 (80%), p = .591]. In addition, oral paracetamol was as safe as oral ibuprofen in terms of gastrointestinal perforation or bleeding, necrotizing

Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity: A Randomized Clinical Noninferiority Trial.

PubMed

Lavizzari, Anna; Colnaghi, Mariarosa; Ciuffini, Francesca; Veneroni, Chiara; Musumeci, Stefano; Cortinovis, Ivan; Mosca, Fabio

2016-08-08

Heated, humidified high-flow nasal cannula (HHHFNC) has gained increasing popularity as respiratory support for newborn infants thanks to ease of use and improved patient comfort. However, its role as primary therapy for respiratory distress syndrome (RDS) of prematurity needs to be further elucidated by large, randomized clinical trials. To determine whether HHHFNC provides respiratory support noninferior to nasal continuous positive airway pressure (nCPAP) or bilevel nCPAP (BiPAP) as a primary approach to RDS in infants older than 28 weeks' gestational age (GA). An unblinded, monocentric, randomized clinical noninferiority trial at a tertiary neonatal intensive care unit. Inborn infants at 29 weeks 0 days to 36 weeks 6 days of GA were eligible if presenting with mild to moderate RDS requiring noninvasive respiratory support. Criteria for starting noninvasive respiratory support were a Silverman score of 5 or higher or a fraction of inspired oxygen higher than 0.3 for a target saturation of peripheral oxygen of 88% to 93%. Infants were ineligible if they had major congenital anomalies or severe RDS requiring early intubation. Infants were enrolled between January 5, 2012, and June 28, 2014. Randomization to either HHHFNC at 4 to 6 L/min or nCPAP/BiPAP at 4 to 6 cm H2O. Need for mechanical ventilation within 72 hours from the beginning of respiratory support. The absolute risk difference in the primary outcome and its 95% confidence interval were calculated to determine noninferiority (noninferiority margin, 10%). An intention-to-treat analysis was performed. A total of 316 infants were enrolled in the study: 158 in the HHHFNC group (mean [SD] GA, 33.1 [1.9] weeks; 52.5% female) and 158 in the nCPAP/BiPAP group (mean [SD] GA, 33.0 [2.1] weeks; 47.5% female). The use of HHHFNC was noninferior to nCPAP with regard to the primary outcome: failure occurred in 10.8% vs 9.5% of infants, respectively (95% CI of risk difference, -6.0% to 8.6% [within the noninferiority

Tuberculous otitis in infants: temporal bone histopathology and clinical extrapolation.

PubMed

Nicolau, Yamileth; Northrop, Clarinda; Eavey, Roland

2006-08-01

The study of infant temporal bones with tuberculosis (TB) of the middle ear and mastoid could provide information to assist with clinical diagnosis in this population. The TB pandemic has become a critical global public health problem. With the rising incidence of the disease, otolaryngologists might encounter an increased frequency of otologic TB. Pediatric temporal bone reports of TB are rare. Light microscopic examination was performed on both temporal bones from an infant who died as a result of miliary TB. The tympanic membranes were thickened with dilated blood vessels, yet were intact without perforations. Purulence, granulation tissue, and classic tubercles were observed in the middle ears and mastoids. Serous labyrinthitis and inflammatory cells surrounding the Cranial Nerve VIII in the internal auditory canal were observed in the inner ear. The histological findings suggest that a clinical presentation of infantile tuberculous otitis media and mastoiditis could be a patient with otoscopic findings consistent with common otitis media with an intact tympanic membrane, likely in conjunction with inner ear symptoms. Lacking the classic finding of multiple tympanic membrane perforations, tuberculous otitis might be underappreciated in this population.

Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco smoke exposure on infant lung function and respiratory health.

PubMed

McEvoy, Cindy T; Milner, Kristin F; Scherman, Ashley J; Schilling, Diane G; Tiller, Christina J; Vuylsteke, Brittany; Shorey-Kendrick, Lyndsey E; Spindel, Eliot R; Schuff, Robert; Mitchell, Julie; Peters, Dawn; Metz, Jill; Haas, David; Jackson, Keith; Tepper, Robert S; Morris, Cynthia D

2017-07-01

Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective effect of vitamin C supplementation on the lung function of offspring exposed to in utero smoke in a non-human primate model and an initial human trial. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) is a randomized, double-blind, placebo-controlled trial to evaluate pulmonary function at 3months of age in infants delivered to pregnant smokers randomized to 500mg/day of vitamin C versus placebo during pregnancy. Secondary aims evaluate the incidence of wheezing through 12months and pulmonary function testing at 12months of age. Women are randomized between 13 and 23weeks gestation from clinical sites in Portland, Oregon at Oregon Health & Science University and PeaceHealth Southwest Medical Center and in Indianapolis, Indiana at Indiana University and Wishard Hospital. Vitamin C supplementation occurs from randomization to delivery. Monthly contact with participants and monitoring of medical records is performed to document medication adherence, changes in smoking and medical history, and adverse events. Pulmonary function testing of offspring occurs at 3 and 12months of age and incidence of wheezing and respiratory illness through 12months is captured via at least quarterly questionnaires. Ancillary studies are investigating the impact of vitamin C on placental blood flow and DNA methylation. Copyright © 2017 Elsevier Inc. All rights reserved.

Avoidance of Cow's Milk-Based Formula for At-Risk Infants Does Not Reduce Development of Celiac Disease: A Randomized Controlled Trial.

PubMed

Hyytinen, Mila; Savilahti, Erkki; Virtanen, Suvi M; Härkönen, Taina; Ilonen, Jorma; Luopajärvi, Kristiina; Uibo, Raivo; Vaarala, Outi; Åkerblom, Hans K; Knip, Mikael

2017-10-01

Feeding during the first months of life might affect risk for celiac disease. Individuals with celiac disease or type 1 diabetes have been reported to have high titers of antibodies against cow's milk proteins. Avoidance of cow's milk-based formula for infants with genetic susceptibility for type 1 diabetes reduced the cumulative incidence of diabetes-associated autoantibodies. We performed a randomized controlled trial in the same population to study whether weaning to an extensively hydrolyzed formula reduced the risk of celiac disease autoimmunity or celiac disease. We performed a double-blind controlled trial of 230 infants with HLA-defined predisposition to type 1 diabetes and at least 1 family member with type 1 diabetes. The infants were randomly assigned to groups fed a casein hydrolysate formula (n = 113) or a conventional formula (control, n = 117) whenever breast milk was not available during the first 6-8 months of life. Serum samples were collected over a median time period of 10 years and analyzed for antibodies to tissue transglutaminase (anti-TG2A) using a radiobinding assay, to endomysium using an immunofluorescence assay, and antibodies to a deamidated gliadine peptide using an immunofluorometry assay. Duodenal biopsies were collected if levels of anti-TG2A exceeded 20 relative units. Cow's milk antibodies were measured during the first 2 years of life. Of the 189 participants analyzed for anti-TG2A, 25 (13.2%) tested positive. Of the 230 study participants observed, 10 (4.3%) were diagnosed with celiac disease. We did not find any significant differences at the cumulative incidence of anti-TG2A positivity (hazard ratio, 1.14; 95% confidence interval, 0.51-2.54) or celiac disease (hazard ratio, 4.13; 95% confidence interval, 0.81-21.02) between the casein hydrolysate and cow's milk groups. Children who developed celiac disease had increased titers of cow's milk antibodies before the appearance of anti-TG2A or celiac disease. In a randomized

Promotion of early pediatric hearing detection through patient navigation: A randomized controlled clinical trial.

PubMed

Bush, Matthew L; Taylor, Zachary R; Noblitt, Bryce; Shackleford, Taylor; Gal, Thomas J; Shinn, Jennifer B; Creel, Liza M; Lester, Cathy; Westgate, Philip M; Jacobs, Julie A; Studts, Christina R

2017-11-01

To assess the efficacy of a patient navigator intervention to decrease nonadherence to obtain audiological testing following failed screening, compared to those receiving the standard of care. Using a randomized controlled design, guardian-infant dyads, in which the infants had abnormal newborn hearing screening, were recruited within the first week after birth. All participants were referred for definitive audiological diagnostic testing. Dyads were randomized into a patient navigator study arm or standard of care arm. The primary outcome was the percentage of patients with follow-up nonadherence to obtain diagnostic testing. Secondary outcomes were parental knowledge of infant hearing testing recommendations and barriers in obtaining follow-up testing. Sixty-one dyads were enrolled in the study (patient navigator arm = 27, standard of care arm = 34). The percentage of participants nonadherent to diagnostic follow-up during the first 6 months after birth was significantly lower in the patient navigator arm compared with the standard of care arm (7.4% vs. 38.2%) (P = .005). The timing of initial follow-up was significantly lower in the navigator arm compared with the standard of care arm (67.9 days after birth vs. 105.9 days, P = .010). Patient navigation increased baseline knowledge regarding infant hearing loss diagnosis recommendations compared with the standard of care (P = .004). Patient navigation decreases nonadherence rates following abnormal infant hearing screening and improves knowledge of follow-up recommendations. This intervention has the potential to improve the timeliness of delivery of infant hearing healthcare; future research is needed to assess the cost and feasibility of larger scale implementation. 1b. Laryngoscope, 127:S1-S13, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction.

PubMed

Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2011-10-01

This study tested the efficacy of a brief intervention (Cues program) with mothers of very low birth weight (VLBW <1500 g) infants. The primary hypothesis was that mothers in the Cues program would report lower levels of anxiety compared with mothers in the control group. Secondary hypotheses examined whether Cues mothers would report less stress, depression, and role restriction, and exhibit more sensitive interactive behavior, than control group mothers. A total of 121 mothers of VLBW infants were randomly assigned to either the experimental (Cues) intervention or an attention control (Care) condition. The Cues program combined training to reduce anxiety and enhance sensitivity. The control group received general information about infant care. Both programs were initiated during the neonatal intensive care unit stay. Maternal anxiety, stress, depression, and demographic variables were evaluated at baseline, prior to randomization. Postintervention outcomes were assessed during a home visit when the infant was ∼6 to 8 weeks of corrected age. Although mothers in the Cues group demonstrated greater knowledge of the content of the experimental intervention than mothers in the Care group, the groups did not differ in levels of anxiety, depression, and symptoms of posttraumatic stress. They were similar in their reports of parental role restrictions and stress related to the infant's appearance and behavior. Cues and Care group mothers were equally sensitive in interaction with their infants. Nonspecific attention was as effective as an early skill-based intervention in reducing maternal anxiety and enhancing sensitive behavior in mothers of VLBW infants.

Clinical research on intelligence seven needle therapy treated infants with brain damage syndrome.

PubMed

Liu, Zhen-Huan; Li, Ye-Rong; Lu, Yong-Lin; Chen, Jie-Kui

2016-06-01

To assess whether the intelligence seven needle therapy administered in infants with perinatal brain damage syndrome (BDS) as early intervention would improve patients' neural development. A randomized controlled trial was conducted. Sixty-four infants with BDS were randomly assigned to two groups: the comprehensive group and the control group. Both groups received routine early intervention; in addition, the comprehensive group received intelligence seven needle therapy. Before and after treatment, the Bayley Scale of Infant Development (BSID), Gesell Developmental Schedules, Gross Motor Function Measure (GMFM), transcranial doppler ultrasound (TCD), and cranial imaging examination were tested for contrast. After treatment, the comprehensive group showed significant difference in the Mental Development Index (MDI) scores of BSID compared with the control group (P<0.05), however, no significant discrepancy in psychomotor development index (PDI,P>0.05) was observed. The children's development quotients (DQ) of the comprehensive group exhibited a significant superiority in improving the social adaptation DQ of Gesell Developmental Schedules compared with the control group (P<0.01), as well as GMFM and linguistic and social intercourse (P<0.05). Again, no discrepancy in the fine movement DQ was found (P>0.05). The total scores of GMFM in the comprehensive group were higher than those in the control group (P<0.05). Comparing the two groups, the comprehensive group showed a significantly greater recovery rate than the control group on TCD after treatment (P<0.05). After 6-month follow-up, some recovery in both groups, specifically on broadening of brain outside space by cranial imaging examination were observed. The comprehensive group demonstrated a significantly greater recovery rate than the control group (P<0.05). The developmental level of intelligence, motion function, linguistic competence and social intercourse can be promoted for infants with perinatal BDS by

[Laboratory and clinical studies on flomoxef in neonates and premature infants].

PubMed

Motohiro, T; Maruoka, T; Nagai, K; Oki, S; Tsumura, N; Sasaki, H; Aramaki, M; Koga, T; Sakata, Y; Tominaga, K

1993-07-01

Flomoxef (FMOX), an oxacephem antibiotic of beta-lactam antibiotic family, was administered to 16 infants including 6 neonates and 10 premature infants at a dose of 20 or 40 mg/kg via intravenous injection, and plasma and urinary concentrations and the urinary recovery were determined. In addition, FMOX was administered via intravenous injection at daily doses averaging 85.5 mg/kg divided into 2 to 4 times for durations averaging 9 days to 96 infants from 0- to 90-day old (mainly neonates and premature infants). In 44 of the 96 infants with bacterial infections, clinical and bacteriological efficacies were evaluated, and prophylactic effects of FMOX were determined in the remaining 52 infants. Adverse reaction and laboratory tests abnormalities were evaluated also. The obtained results are summarized as follows. 1. Upon administration of FMOX at 20 or 40 mg/kg to neonates and premature infants via intravenous injection, plasma concentrations, half-lives and AUC were determined. In 3 neonates of 5, 7 and 16 days of ages administered with 20 mg/kg of FMOX, peak plasma concentrations of 62.5 to 99.7 micrograms/ml were achieved in 5 or 15 minutes after injection. Half-lives of FMOX in these neonates were 1.48 to 1.78 hours and AUC's were 112 to 161 micrograms.hr/ml. The same dose (20 mg/kg) of FMOX was administered to 3 premature infants of 5- 16- and 19-day of ages and initial blood samples were obtained at 5 minutes after injection from the 5-day old subject and at 15 minutes after injection from the 16-and 19-day old subjects. Peak plasma concentrations of 63.6 to 79.9 micrograms/ml were observed in the samples. Half-lives were 1.69 to 2.20 hours and AUC's were 174 to 201 micrograms.hr/ml. When 3 neonates (one 17-day old and two 24-day old subjects) were administered with 40 mg/kg of FMOX, peak plasma concentrations obtained at 5 minutes after injection were 99.7 to 122.0 micrograms/ml. Half-lives were 1.28 to 1.92 hours and AUC's were 170 to 357 micrograms

Commercial discharge packs and breast-feeding counseling: effects on infant-feeding practices in a randomized trial.

PubMed

Frank, D A; Wirtz, S J; Sorenson, J R; Heeren, T

1987-12-01

A randomized controlled trial was conducted to evaluate two interventions for prolonging the duration of breast-feeding in a multiethnic sample of 343 low-income urban women. One intervention compared research breast-feeding bedside counseling by a trained counselor, who also made eight telephone calls during the first 3 months of the infant's life, with the routine breast-feeding counseling provided in the hospital by nurses. The other intervention compared commercial discharge packs provided by formula companies with research discharge packs designed to be consistent with the WHO Code of Marketing of Breastmilk Substitutes. When infants were 4 months old, a telephone interviewer unaware of treatment status contacted 95% (324/343) of the women to determine the infants' feeding and health histories. Compared with routine counseling, research counseling delayed the first introduction of solid foods to the infant's diet (P = .03, one-tailed) but did not exert a statistically significant effect on breast-feeding by 4 months' postpartum. Women who received the research discharge pack, compared with those who received the commercial pack, were more likely to prolong exclusive breast-feeding (P = .004, one-tailed), to be partially breast-feeding at 4 months postpartum (P = .04, one-tailed), and to delay the daily use of solid foods in the infant's diet (P = .017, one-tailed). Among the women who received research counseling, the research discharge pack was associated with lower rates of rehospitalization of infants than was the commercial pack (1% v 14%; P = .014, two-tailed). We conclude that in high-risk maternity populations, commercial discharge materials for breast-feeding women should be replaced by materials consistent with the WHO Code.

Iron deficiency anaemia in Nigerian infants.

PubMed

Akinkugbe, F M; Ette, S I; Durowoju, T A

1999-01-01

Hematological parameters and the iron status of 50 randomly selected infants who were attending the research infant welfare clinic of the Institute of Child Health, Ibadan (ICHI), for routine immunization were studied. Investigations included estimations of packed cell volume (PCV), haemoglobin (Hb), serum iron (Fe), unsaturated iron-binding capacity (UIBC) and total iron-binding Capacity (TIBC). Forty percent of the infants had PCVs below 0.32, 48% had Hbs below 10 g/dl and 27% had mean corpuscular volume (MVC) less that 70fl. Thirty-seven percent of the children had serum Fe below 3.58 mmol/l, but only 4% had UIBC above 320 mmol/l. Fifty-two percent had Transferin Saturation Index (TSI) below 10%. Eighteen percent had MCV below 70fl associated with TSI below 10% and 67% of these had Hbs below 10 g/dl. The prevalence of iron deficiency anaemia in infants as shown in this study is very high. The ill effects of iron deficiency in childhood have been well documented. It is suggested that screening for anaemia should be offered at 9 months as part of a Child Survival Programme and that infants found to be anaemic should be treated. However, for cost-effectiveness and taking into consideration the high prevalence rate of iron deficiency in this age group, it might be preferable to give iron and weekly prophylactic antimalarias routinely to infants aged 9 to 15 months in lieu of screening.

Effect of postnatal home visits on maternal/infant outcomes in Syria: a randomized controlled trial.

PubMed

Bashour, Hyam N; Kharouf, Mayada H; Abdulsalam, Asma A; El Asmar, Khalil; Tabbaa, Mohammed A; Cheikha, Salah A

2008-01-01

Early postpartum home visiting is universal in many Western countries. Studies from developing countries on the effects of home visits are rare. In Syria, where the postpartum period is rather ignored, this study aimed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities; infant morbidity; uptake of postpartum care; use of contraceptive methods; and on selected neonatal health practices. A randomized controlled trial was carried out in Damascus. Three groups of new mothers were randomly allocated to receive either 4 postnatal home visits (A), one visit (B), or no visit (C). A total of 876 women were allocated and followed up. Registered midwives with special training made a one or a series of home visits providing information, educating, and supporting women. A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants (28.5% and 30%, respectively) as compared with Group C (20%), who received no visits. There were no reported differences between groups in other outcomes. While postpartum home visits significantly increased exclusive breastfeeding, other outcomes did not change. Further studies framed in a nonbiomedical context are needed. Other innovative approaches to improve postnatal care in Syria are needed.

To compare growth outcomes and cost-effectiveness of "Kangaroo ward care" with "intermediate intensive care" in stable extremely low birth weight infants: randomized control trial.

PubMed

Sharma, Deepak; Murki, Srinivas; Pratap, Oleti Tejo

2017-07-01

To compare growth outcome and cost-effectiveness of "Kangaroo ward care" (KWC) with "Intermediate intensive care" (IIC) in stable extremely low birth weight (ELBW) infants. This is secondary analysis of the study and we analyzed 62 ELBW infants, 33 were randomized to KWC and 29 to IIC once the infant reached a weight of 1150 g. Infants in the KWC group were shifted to the Kangaroo ward immediately after randomization and in the IIC group received IIC care till they attain a weight of 1250 g before shifting to Kangaroo ward. The gain in weight (g/day), length (cm/week), and head circumference (cm/week) were comparable between the two groups. The mean weight, length, and head circumference were comparable at term gestational age. The infants in KWC group were shifted five days earlier to Kangaroo ward when compared to IIC group. The cost-effective analysis using "top-down" and "bottom-up" accounting method showed that there was significant reduction of hospital and parents expenditure in KWC group (p < 0.001) with approximate saving of 452 USD for each patient in the KWC group. Early shifting of ELBW infants for KWC is very efficacious and cost-effective intervention when compared to IIC. (CTRI/2014/05/004625).

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

Tolerance of young infants to a single, large dose of vitamin A: a randomized community trial in Nepal.

PubMed

West, K P; Khatry, S K; LeClerq, S C; Adhikari, R; See, L; Katz, J; Shrestha, S R; Pradhan, E K; Pokhrel, R P; Sommer, A

1992-01-01

A randomized, double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates ( < 1 month of age) and infants aged 1-6 months who received a large, oral dose of vitamin A (15,000 retinol equivalents (RE) (50,000 IU) and 30,000 RE (100,000 IU), respectively) or placebo (75 RE (250 IU) and 150 RE (500 IU), respectively) in oil. Infants (vitamin A group, n = 1461; controls, n = 1379) were assessed for vomiting, loose stools, fever, and irritability during the 24 hours before and after dosing. Fontanelles were palpated 24 hours after dosing. Neonates exhibited no excess risk of adverse side-effects after receiving 15,000 RE. Compared with controls the older infants who ingested 30,000 RE had a 1.6% excess rate of vomiting (95% confidence interval (CI): 0.2-3.0%) and a 0.5% excess rate (95% CI: -0.1 to 1.1%) in the occurrence of bulging fontanelles. There were no other significant differences in the older infants. The controlled, periodic distribution of a single 15,000 RE dose of vitamin A therefore confers no apparent acute risk to young infants; a 30,000 RE dose is associated with a minimum risk of transient, acute side-effects.

Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial.

PubMed

Cooijmans, Kelly H M; Beijers, Roseriet; Rovers, Anne C; de Weerth, Carolina

2017-07-06

Twenty-to-forty percent of women experience postpartum depressive symptoms, which can affect both the mother and infant. In preterm infants, daily skin-to-skin contact (SSC) between the mother and her infant has been shown to decrease maternal postpartum depressive symptoms. In full-term infants, only two studies investigated SSC effects on maternal depressive symptoms and found similar results. Research in preterm infants also showed that SSC improves other mental and physical health outcomes of the mother and the infant, and improves the quality of mother-infant relationship. This randomized controlled trial will investigate the effects of a SSC intervention on maternal postpartum depressive symptoms and additional outcomes in mothers and their full-term infants. Moreover, two potential underlying mechanisms for the relation between SSC and the maternal and infant outcomes will be examined, namely maternal oxytocin concentrations and infant intestinal microbiota. Design: A parallel-group randomized controlled trial. 116 mothers and their full-term infants. Mothers in the SSC condition will be requested to provide daily at least one continuous hour of SSC to their infant. The intervention starts immediately after birth and lasts for 5 weeks. Mothers in the control condition will not be requested to provide SSC. Maternal and infant outcomes will be measured at 2 weeks, 5 weeks, 12 weeks and 1 year after birth. maternal postpartum depressive symptoms. Secondary maternal outcomes: mental health (anxiety, stress, traumatic stress following child birth, sleep quality), physical health (physical recovery from the delivery, health, breastfeeding, physiological stress), mother-infant relationship (mother-infant bond, quality of maternal caregiving behavior). Secondary infant outcomes: behavior (fussing and crying, sleep quality), physical health (growth and health, physiological stress), general development (regulation capacities, social-emotional capacities

Heterologous Immunological Effects of Early BCG Vaccination in Low-Birth-Weight Infants in Guinea-Bissau: A Randomized-controlled Trial

PubMed Central

Jensen, Kristoffer Jarlov; Larsen, Nanna; Biering-Sørensen, Sofie; Andersen, Andreas; Eriksen, Helle Brander; Monteiro, Ivan; Hougaard, David; Aaby, Peter; Netea, Mihai G.; Flanagan, Katie L.; Benn, Christine Stabell

2015-01-01

Background. Bacillus Calmette–Guérin (BCG) seems to have beneficial nonspecific effects; early BCG vaccination of low-birth-weight (LBW) newborns reduces neonatal mortality by >40% due to prevention of primarily septicemia and pneumonia. Methods. Within a randomized trial in LBW infants in Guinea-Bissau of early BCG vs the usual postponed BCG, a subgroup was bled 4 weeks after randomization. Levels of interleukin (IL)-1β, IL-5, IL-6, IL-10, IL-17, interferon (IFN)-γ and tumor necrosis factor (TNF)-α were measured from whole-blood assays stimulated with innate agonists to Toll-like receptor (TLR)-2, -4 or -7/8, or purified protein derivative (PPD). Results. Among 467 infants, BCG significantly increased the in vitro cytokine responses to purified protein derivative of Mycobacterium tuberculosis (PPD), as expected. BCG was also associated with increased responses to heterologous innate stimulation, particularly of the cytokines IL-1β, IL-6, TNF-α, and IFN-γ. Conclusion. Four weeks after immunization, BCG-vaccinated infants have a significantly increased production of cytokines upon heterologous challenge, particularly T helper cell type 1 polarizing and typically monocyte-derived pro-inflammatory cytokines. BCG may accelerate the development of the neonatal immune system, mediating comprehensive protection against infections and mortality. PMID:25210141

Teaching attachment behaviors to pregnant women: a randomized controlled trial of effects on infant mental health from birth to the age of three months.

PubMed

Akbarzadeh, Marzieh; Dokuhaki, Akram; Joker, Azam; Pishva, Narges; Zare, Najaf

2016-01-01

Maternal-fetal attachment, which forms as soon as pregnancy starts, is essential to an infant's mental development. This study aimed to explore the effect of teaching attachment behaviors to pregnant women on infant mental health from birth to 3 months of age. Randomized controlled trial. Hafiz Hospital, Shiraz University of Medical Sciences, Iran, from February to November 2014. The participants were randomly divided into an intervention and a control group at 28-34 weeks gestation. The participants in the intervention group attended six educational sessions each lasting for 60-90 minutes. After delivery, the infants of mothers in each group were compared in terms of mental health indexes (total mean scores and scores derived from a checklist of questions for infant mental health with results categorized as low, average and high). Maternal anxiety levels were also recorded at birth and at 3 months. Infant mental health index. In 190 pregnant women (96 in the intervention group and 94 in the control group), the total mean (SD) scores for infant mental health at birth were 16.66 (1.51) in the intervention group and 16.07 (1.74) in the control group (P=.013). At 3 months, the total mental health scores infants were 31.05 (1.88) in the intervention group and 30.25 (2.10) in the control group (P=.007). Differences in checklist scores between the groups at 3 months were not statistically significant, except for crying intensity at 3 months (P=.021). Women in the control group had higher anxiety levels at 3 months (P=.01). Teaching attachment skills to mothers increased the attachment between the mothers and their infants, and consequently, improved infant mental health. Thus, teaching attachment skills should be incorporated into routine prenatal care. Use of phone calls by the researcher to assess mental health.

The Effect of the Infant Behavioral Assessment and Intervention Program on Mother-Infant Interaction after Very Preterm Birth

ERIC Educational Resources Information Center

Meijssen, Dominique; Wolf, Marie-Jeanne; Koldewijn, Karen; Houtzager, Bregje A.; Van Wassenaer, Aleid; Tronick, Ed; Kok, Joke; Van Baar, Anneloes

2010-01-01

Background: Prematurity and perinatal insults lead to increased developmental vulnerability. The home-based Infant Behavioral Assessment and Intervention Program (IBAIP) was designed to improve development of preterm infants. In a multicenter randomized controlled trial the effect of IBAIP on mother-infant interaction was studied as a secondary…

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study

PubMed Central

2014-01-01

Background Because early life growth has long-lasting metabolic and behavioral consequences, intervention during this period of developmental plasticity may alter long-term obesity risk. While modifiable factors during infancy have been identified, until recently, preventive interventions had not been tested. The Intervention Nurses Starting Infants Growing on Healthy Trajectories (INSIGHT). Study is a longitudinal, randomized, controlled trial evaluating a responsive parenting intervention designed for the primary prevention of obesity. This “parenting” intervention is being compared with a home safety control among first-born infants and their parents. INSIGHT’s central hypothesis is that responsive parenting and specifically responsive feeding promotes self-regulation and shared parent–child responsibility for feeding, reducing subsequent risk for overeating and overweight. Methods/Design 316 first-time mothers and their full-term newborns were enrolled from one maternity ward. Two weeks following delivery, dyads were randomly assigned to the “parenting” or “safety” groups. Subsequently, research nurses conduct study visits for both groups consisting of home visits at infant age 3–4, 16, 28, and 40 weeks, followed by annual clinic-based visits at 1, 2, and 3 years. Both groups receive intervention components framed around four behavior states: Sleeping, Fussy, Alert and Calm, and Drowsy. The main study outcome is BMI z-score at age 3 years; additional outcomes include those related to patterns of infant weight gain, infant sleep hygiene and duration, maternal responsiveness and soothing strategies for infant/toddler distress and fussiness, maternal feeding style and infant dietary content and physical activity. Maternal outcomes related to weight status, diet, mental health, and parenting sense of competence are being collected. Infant temperament will be explored as a moderator of parenting effects, and blood is collected to obtain genetic

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study.

PubMed

Paul, Ian M; Williams, Jennifer S; Anzman-Frasca, Stephanie; Beiler, Jessica S; Makova, Kateryna D; Marini, Michele E; Hess, Lindsey B; Rzucidlo, Susan E; Verdiglione, Nicole; Mindell, Jodi A; Birch, Leann L

2014-07-18

Because early life growth has long-lasting metabolic and behavioral consequences, intervention during this period of developmental plasticity may alter long-term obesity risk. While modifiable factors during infancy have been identified, until recently, preventive interventions had not been tested. The Intervention Nurses Starting Infants Growing on Healthy Trajectories (INSIGHT). Study is a longitudinal, randomized, controlled trial evaluating a responsive parenting intervention designed for the primary prevention of obesity. This "parenting" intervention is being compared with a home safety control among first-born infants and their parents. INSIGHT's central hypothesis is that responsive parenting and specifically responsive feeding promotes self-regulation and shared parent-child responsibility for feeding, reducing subsequent risk for overeating and overweight. 316 first-time mothers and their full-term newborns were enrolled from one maternity ward. Two weeks following delivery, dyads were randomly assigned to the "parenting" or "safety" groups. Subsequently, research nurses conduct study visits for both groups consisting of home visits at infant age 3-4, 16, 28, and 40 weeks, followed by annual clinic-based visits at 1, 2, and 3 years. Both groups receive intervention components framed around four behavior states: Sleeping, Fussy, Alert and Calm, and Drowsy. The main study outcome is BMI z-score at age 3 years; additional outcomes include those related to patterns of infant weight gain, infant sleep hygiene and duration, maternal responsiveness and soothing strategies for infant/toddler distress and fussiness, maternal feeding style and infant dietary content and physical activity. Maternal outcomes related to weight status, diet, mental health, and parenting sense of competence are being collected. Infant temperament will be explored as a moderator of parenting effects, and blood is collected to obtain genetic predictors of weight status. Finally, second

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M J

2005-07-20

time to regain birthweight (one study). However, the duration of supportive care given to infants was significantly reduced (MD -162.1 mins/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or hospital stay. Comparing phenobarbitone with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment reported by treatment group of allocation were available. No trials were eligible that assessed clonidine for NAS. In infants treated with an opiate, a small quasi-random study reported a reduced severity of withdrawal. Infants were weaned from an opiate more quickly which allowed earlier hospital discharge and reduced hospital costs. These findings may reflect the low dose of opiate used for initial treatment and the policy of discharging infants home on phenobarbitone but not morphine. In newborn infants with NAS, there is no evidence that phenobarbitone compared with supportive care alone reduces treatment failure; however, phenobarbitone may reduce the daily duration of supportive care needed. Phenobarbitone, compared to diazepam, reduces treatment failure. In infants treated with an opiate, the addition of phenobarbitone may reduce withdrawal severity. Further trials are required to determine if this finding is applicable when a higher initial dose of opiate is used, and determine the effects of phenobabritone on infant development. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. This review should be taken in conjunction with the review "Opiate treatment for opiate withdrawal in newborn infants" (Osborn 2002a) which indicates that an opiate is the

Randomized trial of nutrient-enriched formula versus standard formula for postdischarge preterm infants.

PubMed

Lucas, A; Fewtrell, M S; Morley, R; Singhal, A; Abbott, R A; Isaacs, E; Stephenson, T; MacFadyen, U M; Clements, H

2001-09-01

Preterm infants are frequently discharged from the hospital growth retarded and show reduced growth throughout childhood. In a large efficacy and safety trial, we tested the hypothesis that nutritional intervention in the first 9 months postterm would reverse postdischarge growth deficits and improve neurodevelopment without adverse safety outcomes. Two hundred eighty-four infants (mean gestation: 30.9 weeks) were studied; 229 were randomly assigned a protein, energy, mineral, and micronutrient-enriched postdischarge formula (PDF; N = 113) or standard term formula (TF; N = 116) from discharge (mean 36.5 weeks' postmenstrual age). A reference group (N = 65) was breastfed until at least 6 weeks' postterm. Outcome measures. Anthropometry was performed at 6 weeks and 3, 6, 9, and 18 months. Development was measured at 9 months (Knobloch, Passamanick, and Sherrard's developmental screening inventory) and 18 months (Bayley Scales of Infant Development II; primary outcome) postterm. At 9 months, compared with the TF group, those fed PDF were heavier (difference 370 g; 95% confidence interval [CI]: 84-660) and longer (difference 1.1 cm; 95% CI: 0.3-1.9); the difference in length persisted at 18 months (difference 0.82 cm; 95% CI: -0.04-1.7). There was no effect on head circumference. The effect of diet was greatest in males; at 9 months length deficit with TF was 1.5cm (95% CI: 0.3-2.7), and this remained at 18 months (1.5cm [95% CI: 0.3-2.7]). There was no significant difference in developmental scores at 9 or 18 months, although PDF infants had a 2.8 (-1.3-6.8) point advantage in Bayley motor score scales. At 6 weeks' postterm, exclusively breastfed infants were already 513 g (95% CI: 310-715) lighter and 1.6cm (95% CI: 0.8-2.3) shorter than the PDF group, and they remained smaller up to 9 months' postterm. 1) Improving postdischarge nutrition in the first 9 months may "reset" subsequent growth-at least until 18 months for body length. We intend to follow-up the children

Every three-hour versus every six-hour oral feeding in preterm infants: a randomised clinical trial.

PubMed

Gray, Megan M; Medoff-Cooper, Barbara; Enlow, Elizabeth M; Mukhopadhyay, Sagori; DeMauro, Sara B

2017-02-01

This trial compares two oral feeding schedules, every three-hour and every six-hour oral feeding attempts, to determine which schedule allows for more rapid attainment of full oral feeding in preterm infants. Infants born at ≤33-week gestation were randomly assigned to receive oral feeding every three hours or every six hours if feeding cues were present. The primary outcome was time to full oral feeding; secondary outcomes include respiratory and apnoea rates, growth and length of stay. A total of 55 infants were recruited. There was no difference between the groups in the primary or secondary outcomes. For preterm infants fed when oral feeding cues are present, an every six-hour schedule did not alter the time to full oral feeding and had no effect on rates of tachypnoea, apnoea or length of hospital stay compared to every three-hour feeding schedule. An every six-hour oral feeding schedule led to only small reductions in number of oral feeding attempts per day. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Nasal Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

PubMed

Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Goyal, Kanika; Bahl, Pinky; Puliyel, Jacob M

2018-01-15

To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. Participants: 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. The outcome was assessed after 60 minutes. If nCPAP was not tolerated or the distress increased, the infant was switched to standard care. Analysis was done on intention-to-treat basis. Change in respiratory rate, Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score. 14 out of 32 in nCPAP group and 5 out of 35 in standard care group had change in respiratory rate ≥10 (P=0.008). The mean (SD) change in respiratory rate [8.0 (5.8) vs 5.1 (4.0), P=0.02] in Silverman-Anderson score [0.78 (0.87) vs 0.39 (0.73), P=0.029] and in Modified Pediatric Society of New Zealand Severity Score [2.5 (3.01) vs. 1.08 (1.3), P=0.012] were significantly different in the nCPAP and standard care groups, respectively. nCPAP helped reduce respiratory distress significantly compared to standard care.

A pilot randomized controlled trial of time-intensive cognitive-behaviour therapy for postpartum obsessive-compulsive disorder: effects on maternal symptoms, mother-infant interactions and attachment.

PubMed

Challacombe, F L; Salkovskis, P M; Woolgar, M; Wilkinson, E L; Read, J; Acheson, R

2017-06-01

There is increasing recognition that perinatal anxiety disorders are both common and potentially serious for mother and child. Obsessive-compulsive disorder (OCD) can be triggered or exacerbated in the postpartum period, with mothers reporting significant effects on parenting tasks. However, there is little evidence concerning their effective treatment or the impact of successful treatment on parenting. A total of 34 mothers with OCD and a baby of 6 months old were randomized into either time-intensive cognitive-behaviour therapy (iCBT) or treatment as usual (TAU). iCBT took place after randomization at 6 months postpartum and was completed by 9 months. Maternal symptomatology, sensitivity in mother-infant interactions and parenting were assessed at baseline and reassessed at 12 months postpartum. At 12 months attachment was also assessed using Ainsworth's Strange Situation Procedure. A healthy control group of mothers and infants (n = 37) underwent the same assessments as a benchmark. iCBT was successful in ameliorating maternal symptoms of OCD (controlled effect size = 1.31-1.90). However, mother-infant interactions were unchanged by treatment and remained less sensitive in both OCD groups than a healthy control group. The distribution of attachment categories was similar across both clinical groups and healthy controls with approximately 72% classified as secure in each group. iCBT is an effective intervention for postpartum OCD. Sensitive parenting interactions are affected by the presence of postpartum OCD and this is not improved by successful treatment of OCD symptoms. However, the overall attachment bond appears to be unaffected. Longitudinal studies are needed to explore the impact of postpartum OCD as the child develops.

Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials.

PubMed

Szajewska, Hania; Chmielewska, Anna

2013-11-12

Growth is an essential outcome measure for evaluating the safety of any new ingredients, including probiotics, added to infant formulae. The aim of this systematic review was to determine the effects of supplementation of infant formulae with Bifidobacterium lactis Bb12 (B lactis) and/or Lactobacillus rhamnosus GG (LGG) compared with unsupplemented formula on the growth of healthy infants. The MEDLINE, EMBASE, and Cochrane Library databases were searched in June 2013 for relevant randomized controlled trials (RCTs) conducted in healthy term infants. Unpublished data were obtained from the manufacturer of B lactis-supplemented formula. The primary outcome measures were weight, length, and head circumference. Nine eligible trials were identified. Compared with unsupplemented controls, supplementation of infant formula with B lactis had no effect on weight gain [4 RCTs, n = 266, mean difference (MD) 0.96 g/day, 95% confidence interval (CI) -0.70 to 2.63)], length gain (4 RCTs, n = 261, MD -0.39 mm/month, 95% CI -1.32 to 0.53), or head circumference gain (3 RCTs, n = 207, MD 0.56 mm/month, 95% CI -0.17 to 1.30). Data limited to one small (n = 105) trial suggest that infants who received standard infant formula supplemented with LGG grew significantly better. No such effect was observed in infants fed hydrolyzed formula supplemented with LGG. Supplementation of infant formula with B lactis results in growth similar to what is found in infants fed unsupplemented formula. Limited data do not allow one to reach a conclusion regarding the effect of LGG supplementation on infant growth.

A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.

PubMed

Slater, Rebeccah; Hartley, Caroline; Moultrie, Fiona; Adams, Eleri; Juszczak, Ed; Rogers, Richard; Norman, Jane E; Patel, Chetan; Stanbury, Kayleigh; Hoskin, Amy; Green, Gabrielle

2016-11-15

Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 
156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet .

Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial

PubMed Central

Puccio, Giuseppe; Alliet, Philippe; Cajozzo, Cinzia; Janssens, Elke; Corsello, Giovanni; Sprenger, Norbert; Wernimont, Susan; Egli, Delphine; Gosoniu, Laura; Steenhout, Philippe

2017-01-01

ABSTRACT Objectives: The aim of the study was to evaluate the effects of infant formula supplemented with 2 human milk oligosaccharides (HMOs) on infant growth, tolerance, and morbidity. Methods: Healthy infants, 0 to 14 days old, were randomized to an intact-protein, cow's milk–based infant formula (control, n = 87) or the same formula with 1.0 g/L 2′fucosyllactose (2′FL) and 0.5 g/L lacto-N-neotetraose (LNnT) (test, n = 88) from enrollment to 6 months; all infants received standard follow-up formula without HMOs from 6 to 12 months. Primary endpoint was weight gain through 4 months. Secondary endpoints included additional anthropometric measures, gastrointestinal tolerance, behavioral patterns, and morbidity through age 12 months. Results: Weight gain was similar in both groups (mean difference [95% confidence interval] test vs control: −0.30 [−1.94, 1.34] g/day; lower bound of 95% confidence interval was above noninferiority margin [−3 g/day]). Digestive symptoms and behavioral patterns were similar between groups; exceptions included softer stool (P = 0.021) and fewer nighttime wake-ups (P = 0.036) in the test group at 2 months. Infants receiving test (vs control) had significantly fewer parental reports (P = 0.004–0.047) of bronchitis through 4 (2.3% vs 12.6%), 6 (6.8% vs 21.8%), and 12 months (10.2% vs 27.6%); lower respiratory tract infection (adverse event cluster) through 12 months (19.3% vs 34.5%); antipyretics use through 4 months (15.9% vs 29.9%); and antibiotics use through 6 (34.1% vs 49.4%) and 12 months (42.0% vs 60.9%). Conclusions: Infant formula with 2′FL and LNnT is safe, well-tolerated, and supports age-appropriate growth. Secondary outcome findings showing associations between consuming HMO-supplemented formula and lower parent-reported morbidity (particularly bronchitis) and medication use (antipyretics and antibiotics) warrant confirmation in future studies. PMID:28107288

Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial.

PubMed

Puccio, Giuseppe; Alliet, Philippe; Cajozzo, Cinzia; Janssens, Elke; Corsello, Giovanni; Sprenger, Norbert; Wernimont, Susan; Egli, Delphine; Gosoniu, Laura; Steenhout, Philippe

2017-04-01

The aim of the study was to evaluate the effects of infant formula supplemented with 2 human milk oligosaccharides (HMOs) on infant growth, tolerance, and morbidity. Healthy infants, 0 to 14 days old, were randomized to an intact-protein, cow's milk-based infant formula (control, n = 87) or the same formula with 1.0 g/L 2'fucosyllactose (2'FL) and 0.5 g/L lacto-N-neotetraose (LNnT) (test, n = 88) from enrollment to 6 months; all infants received standard follow-up formula without HMOs from 6 to 12 months. Primary endpoint was weight gain through 4 months. Secondary endpoints included additional anthropometric measures, gastrointestinal tolerance, behavioral patterns, and morbidity through age 12 months. Weight gain was similar in both groups (mean difference [95% confidence interval] test vs control: -0.30 [-1.94, 1.34] g/day; lower bound of 95% confidence interval was above noninferiority margin [-3 g/day]). Digestive symptoms and behavioral patterns were similar between groups; exceptions included softer stool (P = 0.021) and fewer nighttime wake-ups (P = 0.036) in the test group at 2 months. Infants receiving test (vs control) had significantly fewer parental reports (P = 0.004-0.047) of bronchitis through 4 (2.3% vs 12.6%), 6 (6.8% vs 21.8%), and 12 months (10.2% vs 27.6%); lower respiratory tract infection (adverse event cluster) through 12 months (19.3% vs 34.5%); antipyretics use through 4 months (15.9% vs 29.9%); and antibiotics use through 6 (34.1% vs 49.4%) and 12 months (42.0% vs 60.9%). Infant formula with 2'FL and LNnT is safe, well-tolerated, and supports age-appropriate growth. Secondary outcome findings showing associations between consuming HMO-supplemented formula and lower parent-reported morbidity (particularly bronchitis) and medication use (antipyretics and antibiotics) warrant confirmation in future studies.

Using daily text messages to improve adherence to infant micronutrient powder (MNP) packets in rural western China: A cluster-randomized controlled trial

PubMed Central

Wang, Xu; Liu, Chengfang; Zhang, Linxiu; Yue, Ai; Medina, Alexis; Rozelle, Scott

2018-01-01

Objective To evaluate the effectiveness of daily text messages as a means to improve caregivers’ adherence to infant micronutrient powder (MNP) in rural Shaanxi Province of China. Methodology 638 infants aged 6–11 months in 234 villages were involved in a cluster-randomized controlled trial (RCT). All caregivers were given free infant MNP packets at baseline in April 2013 and the follow-up survey was in July 2013. We randomly assigned 318 infants in 117 villages to treatment group (receiving daily text message) and 320 infants in the other 117 villages as control group. Results On average, daily text messages increased the number of MNP packets fed (marginal effect = 4.63; 95% confidence interval (CI) = 0.16, 9.10). The text message is more likely to increase the consumption of MNP packets if the primary caregiver was the mother (marginal effect = 12.19; 95% CI = 0.69, 23.68). Receiving the text message appears to significantly increase the likelihood of full adherence when the primary caregiver can either check (odds ratio = 2.93; 95% CI = 1.34, 6.40) or knows how to send (odds ratio = 3.26; 95% CI = 1.53, 6.97) text messages. Conclusion Daily text messages improved the consumption of infant MNP packets. However, the impact was not large enough to increase the probability of caregivers being fully adherent to the feeding instruction, which is to feed 5–7 packets per week as recommended. In addition, when the mother is the caregiver and when the caregiver can check or knows how to send text messages there is greater adherence by the primary caregivers. Trial registration http://www.isrctn.com/ISRCTN44149146 PMID:29352304

Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial.

PubMed

Mukerji, A; Sarmiento, K; Lee, B; Hassall, K; Shah, V

2017-01-01

Non-invasive high-frequency ventilation (NIHFV), a relatively new modality, is gaining popularity despite limited data. We sought to evaluate the effectiveness of NIHFV versus bi-phasic continuous positive airway pressure (BP-CPAP) in preterm infants failing CPAP. Infants with BW<1250 g on CPAP were randomly assigned to NIHFV or BP-CPAP if they met pre-determined criteria for CPAP failure. Infants were eligible for randomization after 72 h age and until 2000 g. Guidelines for adjustment of settings and criteria for failure of assigned mode were implemented. The primary aim was to assess feasibility of a larger trial. In addition, failure of assigned non-invasive respiratory support (NRS) mode, invasive mechanical ventilation (MV) 72 h and 7 days post-randomization, and bronchopulmonary dysplasia (BPD) were assessed. Thirty-nine infants were randomized to NIHFV (N=16) or BP-CPAP (N=23). There were no significant differences in mean (s.d.) postmenstrual age (28.6 (1.5) versus 29.0 (2.3) weeks, P=0.47), mean (s.d.) weight at randomization (965.0 (227.0) versus 958.1 (310.4) g, P=0.94) or other baseline demographics between the groups. Failure of assigned NRS mode was lower with NIHFV (37.5 versus 65.2%, P=0.09), although not statistically significant. There were no differences in rates of invasive MV 72 h and 7 days post-randomization or BPD. NIHFV was not superior to BP-CPAP in this pilot study. Effectiveness of NIHFV needs to be proven in larger multi-center, appropriately powered trials before widespread implementation.

Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women

PubMed Central

Villarreal Pérez, Jesús Zacarías; Ramírez Aranda, José Manuel; de la O Cavazos, Manuel; Zamudio Osuna, Michelle de J.; Perales Dávila, José; Ballesteros Elizondo, María Romelia; Gómez Meza, Marco Vinicio; García Elizondo, Francisco Javier; Rodríguez González, Azucena M.

2017-01-01

ABSTRACT Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined. In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9–139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3–31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8–89.7 and 10.9; 95% CI 8.7–13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours. Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance. PMID:27686182

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Survey of clinical infant lung function testing practices.

PubMed

Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

2014-02-01

Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

Optimizing Clinical Interpretation of Distortion Product Otoacoustic Emissions in Infants.

PubMed

Blankenship, Chelsea M; Hunter, Lisa L; Keefe, Douglas H; Feeney, M Patrick; Brown, David K; McCune, Annie; Fitzpatrick, Denis F; Lin, Li

2018-03-06

in ambient absorbance were found between the NH and SNHL groups. Multifrequency analysis resulted in the best prediction of HL for the SNHL/MHL group with poorer sensitivity values when infants with CHL were included. Clinical interpretation of DPOAEs in infants can be improved by using age-appropriate normative ranges and optimized cutoff values. DPOAE interpretation is most predictive at higher F2 test frequencies in young infants (2-8 kHz) due to poor test performance at 1 to 1.5 kHz. Multifrequency rules can be used to improve sensitivity while balancing specificity. Last, a sensitive middle ear measure such as wideband absorbance should be included in the test battery to assess possibility of a conductive component to the HL.

Relative effectiveness of additive pain interventions during vaccination in infants

PubMed Central

Taddio, Anna; Riddell, Rebecca Pillai; Ipp, Moshe; Moss, Steven; Baker, Stephen; Tolkin, Jonathan; Malini, Dave; Feerasta, Sharmeen; Govan, Preeya; Fletcher, Emma; Wong, Horace; McNair, Caitlin; Mithal, Priyanjali; Stephens, Derek

2017-01-01

BACKGROUND: Vaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life. METHODS: We conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain management for all vaccine injections at 2, 4, 6 and 12 months: (i) placebo control; (ii) parent-directed video education about infant soothing; (iii) the video plus sucrose administered orally or (iv) the video plus sucrose plus liposomal lidocaine applied topically. All infants benefit from injection techniques that minimize pain. We used a double-dummy design; hence all parents watched a video (active psychological intervention or placebo) and all infants received oral solution (sucrose or placebo) and topical cream (lidocaine or placebo). We assessed infant distress during 3 phases — preinjection (baseline), vaccine injection (needle), and 1 minute postinjection (recovery) — using the Modified Behavioural Pain Scale (range 0–10). We compared scores between groups and across infant ages using a mixed-model repeated-measures analysis. RESULTS: A total of 352 infants participated in the study, from Jan. 17, 2012, to Feb. 2, 2016. Demographics did not differ among intervention groups (p > 0.05). Baseline pain scores did not differ among intervention groups (p = 0.4), but did differ across ages (p < 0.001). Needle pain scores differed among groups (p = 0.003) and across ages (p < 0.001). The mean (± standard deviation) needle score was 6.3 (± 0.8) in the video–sucrose–lidocaine group compared with 6.7 (± 0.8) in each of the other groups. There were no other between-group differences. Recovery scores did not differ among groups (p = 0.98), but did differ across ages (p < 0

To Sign or Not to Sign? The Impact of Encouraging Infants to Gesture on Infant Language and Maternal Mind-Mindedness

ERIC Educational Resources Information Center

Kirk, Elizabeth; Howlett, Neil; Pine, Karen J.; Fletcher, Ben C.

2013-01-01

Findings are presented from the first randomized control trial of the effects of encouraging symbolic gesture (or "baby sign") on infant language, following 40 infants from age 8 months to 20 months. Half of the mothers were trained to model a target set of gestures to their infants. Frequent measures were taken of infant language…

Relationship between mother-infant mutual dyadic responsiveness and premature infant development as measured by the Bayley III at 6 weeks corrected age.

PubMed

White-Traut, Rosemary C; Rankin, Kristin M; Yoder, Joe; Zawacki, Laura; Campbell, Suzann; Kavanaugh, Karen; Brandon, Debra; Norr, Kathleen F

2018-06-01

The quality of mother-preterm infant interaction has been identified as a key factor in influencing the infant's later development and language acquisition. The relationship between mother-infant responsiveness and later development may be evident early in infancy, a time period which has been understudied. Describe the relationship between mother-infant mutual dyadic responsiveness and premature infant development. This study employed a secondary analysis of data from the 6-week corrected age (CA) follow-up visit of the Hospital-Home Transition: Optimizing Prematures' Environment (H-HOPE) study, a randomized clinical trial testing the efficacy of a mother- and infant- focused intervention for improving outcomes among premature infants. Premature infants born between 29 and 34 weeks gestational age and their mothers who had social-environmental risks. At 6-weeks corrected age, a play session was coded for the quality of mutual responsiveness (Dyadic Mutuality Code). Development was assessed via the Bayley Scales of Infant and Toddler Development, 3rd edition. Of 137 mother-infant dyads, high, medium and low mutual responsiveness was observed for 35.8%, 34.3% and 29.9%, respectively. Overall motor, language and cognitive scores were 115.8 (SD = 8.2), 108.0 (7.7) and 109.3 (7.9). Multivariable linear models showed infants in dyads with high versus low mutual responsiveness had higher scores on the motor (β = 3.07, p = 0.06) and language (β = 4.47, p = 0.006) scales. High mutual responsiveness in mother-premature infant dyads is associated with significantly better language development and marginally better motor development. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical outcomes of temporary shunting for infants with cerebral pseudomeningocele.

PubMed

Mattei, Tobias A; Sambhara, Deepak; Bond, Brandon J; Lin, Julian

2014-02-01

Although in the case of subdural collections temporary shunting has been suggested as a viable alternative for definitive drainage of the accumulated fluid until restoration of the normal CSF dynamics, there is no agreement on the best management strategy for pseudomeningocele. The authors performed a retrospective chart review in order to evaluate the clinical outcomes of infants temporarily shunted for pseudomeningocele without encephalocele at our institution (The University of Illinois at Peoria/Illinois Neurological Institute) in the period from 2004 to 2012. The epidemiological characteristics, clinical management, and final outcomes of such subpopulation were compared with a control group which received temporary shunting for subdural hematomas (SDH) during the same period. Four patients (100% male) ranging in age from 8.9 to 27.1 months (mean = 13.88) with pseudomeningocele and 17 patients (64.7% male) ranging in age from 1.9 to 11.8 months (mean = 4.15) with SDH were identified. Although the initial management included sequential percutaneous subdural tapping in 82% of the patients, all children ultimately failed such strategy, requiring either subdural-peritoneal (81% of the cases) or subgaleal-peritoneal (19% of the cases) shunting. The mean implant duration was 201 days for the pseudomeningocele group and 384 days for the SDH one. Mean post-shunt hospitalization was 2 days for patients with pseudomeningocele and 4 days for patients with SDH. There was no statistical difference in terms of complications, length of hospitalization post-shunting, or clinical outcomes between the patients with pseudomeningocele and those with SDH. Temporary shunting of infants with pseudo-meningocele constitutes a viable therapeutic alternative with favorable clinical outcomes and a low risk of shunt dependency similar to those of children with SDH.

Nasal Jet-CPAP (variable flow) versus Bubble-CPAP in preterm infants with respiratory distress: an open label, randomized controlled trial.

PubMed

Bhatti, A; Khan, J; Murki, S; Sundaram, V; Saini, S S; Kumar, P

2015-11-01

To compare the failure rates between Jet continuous positive airway pressure device (J-CPAP-variable flow) and Bubble continuous positive airway device (B-CPAP) in preterm infants with respiratory distress. Preterm newborns <34 weeks gestation with onset of respiratory distress within 6 h of life were randomized to receive J-CPAP (a variable flow device) or B-CPAP (continuous flow device). A standardized protocol was followed for titration, weaning and removal of CPAP. Pressure was monitored close to the nares in both the devices every 6 hours and settings were adjusted to provide desired CPAP. The primary outcome was CPAP failure rate within 72 h of life. Secondary outcomes were CPAP failure within 7 days of life, need for surfactant post-randomization, time to CPAP failure, duration of CPAP and complications of prematurity. An intention to treat analysis was done. One-hundred seventy neonates were randomized, 80 to J-CPAP and 90 to B-CPAP. CPAP failure rates within 72 h were similar in infants who received J-CPAP and in those who received B-CPAP (29 versus 21%; relative risks 1.4 (0.8 to 2.3), P=0.25). Mean (95% confidence intervals) time to CPAP failure was 59 h (54 to 64) in the Jet CPAP group in comparison with 65 h (62 to 68) in the Bubble CPAP group (log rank P=0.19). All other secondary outcomes were similar between the two groups. In preterm infants with respiratory distress starting within 6 h of life, CPAP failure rates were similar with Jet CPAP and Bubble CPAP.

Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia.

PubMed

Goode, Rachel H; Rettiganti, Mallikarjuna; Li, Jingyun; Lyle, Robert E; Whiteside-Mansell, Leanne; Barrett, Kathleen W; Casey, Patrick H

2016-12-01

Neonatal hypoglycemia has been associated with abnormalities on brain imaging and a spectrum of developmental delays, although historical and recent studies show conflicting results. We compared the cognitive, academic, and behavioral outcomes of preterm infants with neonatal hypoglycemia with those of normoglycemic controls at 3 to 18 years of age. A secondary analysis of data from the Infant Health and Development Program, a national, multisite, randomized controlled longitudinal intervention study of long-term health and developmental outcomes in preterm infants. Of the 985 infants enrolled in the Infant Health and Development Program, 745 infants had glucose levels recorded. Infants were stratified into 4 groups by glucose level. By using standardized cognitive, academic, and behavioral assessments performed at 3, 8, and 18 years of age, we compared groups after adjusting for intervention status, birth weight, gestational age, sex, severity of neonatal course, race, maternal education, and maternal preconception weight. No significant differences were observed in cognitive or academic skills between the control and effected groups at any age. Participants with more severe neonatal hypoglycemia reported fewer problem behaviors at age 18 than those without hypoglycemia. No significant differences in intellectual or academic achievement were found between preterm infants with and without hypoglycemia. A statistical difference was found in behavior at age 18, with hypoglycemic children showing fewer problematic behaviors than normoglycemic children. This difference was not clinically meaningful. Using extended outcomes, our results are consistent with previous studies that found no significant neurodevelopmental outcomes associated with neonatal hypoglycemia in preterm-born children. Copyright © 2016 by the American Academy of Pediatrics.

Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia

PubMed Central

Rettiganti, Mallikarjuna; Li, Jingyun; Lyle, Robert E.; Whiteside-Mansell, Leanne; Barrett, Kathleen W.; Casey, Patrick H.

2016-01-01

BACKGROUND AND OBJECTIVES: Neonatal hypoglycemia has been associated with abnormalities on brain imaging and a spectrum of developmental delays, although historical and recent studies show conflicting results. We compared the cognitive, academic, and behavioral outcomes of preterm infants with neonatal hypoglycemia with those of normoglycemic controls at 3 to 18 years of age. METHODS: A secondary analysis of data from the Infant Health and Development Program, a national, multisite, randomized controlled longitudinal intervention study of long-term health and developmental outcomes in preterm infants. Of the 985 infants enrolled in the Infant Health and Development Program, 745 infants had glucose levels recorded. Infants were stratified into 4 groups by glucose level. By using standardized cognitive, academic, and behavioral assessments performed at 3, 8, and 18 years of age, we compared groups after adjusting for intervention status, birth weight, gestational age, sex, severity of neonatal course, race, maternal education, and maternal preconception weight. RESULTS: No significant differences were observed in cognitive or academic skills between the control and effected groups at any age. Participants with more severe neonatal hypoglycemia reported fewer problem behaviors at age 18 than those without hypoglycemia. CONCLUSIONS: No significant differences in intellectual or academic achievement were found between preterm infants with and without hypoglycemia. A statistical difference was found in behavior at age 18, with hypoglycemic children showing fewer problematic behaviors than normoglycemic children. This difference was not clinically meaningful. Using extended outcomes, our results are consistent with previous studies that found no significant neurodevelopmental outcomes associated with neonatal hypoglycemia in preterm-born children. PMID:27940690

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial

PubMed Central

2012-01-01

Background Human milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes. Methods/Design In a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study. Discussion The achievement

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial.

PubMed

Giannì, Maria Lorella; Roggero, Paola; Baudry, Charlotte; Ligneul, Amandine; Morniroli, Daniela; Garbarino, Francesca; le Ruyet, Pascale; Mosca, Fabio

2012-10-17

Human milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes. In a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study. The achievement of an appropriate long chain

Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial.

PubMed

Oberhelman, Sara S; Meekins, Michael E; Fischer, Philip R; Lee, Bernard R; Singh, Ravinder J; Cha, Stephen S; Gardner, Brian M; Pettifor, John M; Croghan, Ivana T; Thacher, Tom D

2013-12-01

To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants. Forty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol (vitamin D3) 5000 IU/d for 28 days or 150,000 IU once. Maternal serum, breast milk, and urine were collected on days 0, 1, 3, 7, 14, and 28; infant serum was obtained on days 0 and 28. Enrollment occurred between January 7, 2011, and July 29, 2011. In mothers given daily cholecalciferol, concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL, respectively, from day 3 through 28. In mothers given the single dose, serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL, respectively, at day 1 before rapidly declining. Maternal milk and serum cholecalciferol concentrations were related (r=0.87). Infant mean serum 25-hydroxyvitamin D concentration increased from 17±13 to 39±6 ng/mL in the single-dose group and from 16±12 to 39±12 ng/mL in the daily-dose group (P=.88). All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL. Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants. clinicaltrials.gov NCT01240265. Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

A Cognitive Approach to Child Mistreatment Prevention among Medically At-Risk Infants

ERIC Educational Resources Information Center

Bugental, Daphne Blunt; Schwartz, Alex

2009-01-01

The authors assessed the effectiveness of a home visitation program in enhancing the early parenting history of infants born at medical risk--a population that is at risk for mistreatment. A randomized clinical trial design was used to compare the effects of a cognitively based extension of the Healthy Start home visitation program (HV+) with a…

Lack of Feeding Progression in a Preterm Infant: A Case Study

PubMed Central

White-Traut, Rosemary; Shapiro, Nicole; Healy-Baker, Elissa; Menchavez, Lina; Rankin, Kristin; Medoff-Cooper, Barbara

2012-01-01

Purpose To present the case of a premature infant who displayed immature feeding progression due to nasal occlusion. Subjects Two male preterm infants 33 weeks gestational age at birth from a larger randomized trial. Design Comparative case study. Methods Using a prospective design, feeding assessments were conducted weekly from initiation of oral feeding until hospital discharge. Sucking organization was measured using the Medoff-Cooper Nutritive Sucking Apparatus (M-CNSA) which measured negative sucking pressure generated during oral feedings. Oral and nasogastric (NG) intake and vital signs were recorded. Results At 35 weeks, Infant A demonstrated an immature feeding pattern with NG feedings prevailing over oral feedings. When attempting to feed orally, Infant A exhibited labored breathing and an erratic sucking pattern. During the third weekly feeding evaluation, nasal occlusion was discovered, the NG tube was discontinued, and neosynephrene and humidified air were administered. Following treatment, Infant A’s sucking pattern normalized and the infant maintained complete oral feeding. Infant B demonstrated normal feeding progression. Conclusion Nasal occlusion prevented Infant A from achieving successful oral feeding. The M-CNSA has the ability to help clinicians detect inconsistencies in the breath-suck-swallow feeding patterns of infants and objectively measures patterns of nutritive sucking. The M-CNSA has the potential to influence clinical decision making and identify the need for intervention. PMID:23722488

Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial.

PubMed

de Oliveira, Samira C; Bellanger, Amandine; Ménard, Olivia; Pladys, Patrick; Le Gouar, Yann; Henry, Gwénaële; Dirson, Emelyne; Rousseau, Florence; Carrière, Frédéric; Dupont, Didier; Bourlieu, Claire; Deglaire, Amélie

2017-08-01

It has been suggested that homogenization of Holder-pasteurized human milk (PHM) could improve fat absorption and weight gain in preterm infants, but the impact on the PHM digestive kinetics has never been studied. Our objective was to determine the impact of PHM homogenization on gastric digestion in preterm infants. In a randomized controlled trial, eight hospitalized tube-fed preterm infants were their own control to compare the gastric digestion of PHM and of homogenized PHM (PHHM). PHM was obtained from donors and, for half of it, was homogenized by ultrasonication. Over a six-day sequence, gastric aspirates were collected twice a day, before and 35, 60 or 90 min after the start of PHM or PHHM ingestion. The impact of homogenization on PHM digestive kinetics and disintegration was tested using a general linear mixed model. Results were expressed as means ± SD. Homogenization leaded to a six-fold increase in the specific surface (P < 0.01) of lipid droplets. The types of aggregates formed during digestion were different between PHM and PHHM, but the lipid fraction kept its initial structure all over the gastric digestion (native globules in PHM vs. blend of droplets in PHHM). Homogenization increased the gastric lipolysis level (P < 0.01), particularly at 35 and 60 min (22 and 24% higher for PHHM, respectively). Homogenization enhanced the proteolysis of serum albumin (P < 0.05) and reduced the meal emptying rate (P < 0.001, half-time estimated at 30 min for PHM and 38 min for PHHM). The postprandial gastric pH was not affected (4.7 ± 0.9 at 90 min). Homogenization of PHM increased the gastric lipolysis level. This could be a potential strategy to improve fat absorption, and thus growth and development in infants fed with PHM; however, its gastrointestinal tolerance needs to be investigated further. This trial was registered at clinicaltrials.gov as NCT02112331. Copyright © 2017 European Society for Clinical Nutrition and Metabolism

Comparison of Clinical Efficacy of Newfactan® versus Surfacten® for the Treatment of Respiratory Distress Syndrome in the Newborn Infants

PubMed Central

Choi, Chang Won; Hwang, Jong Hee; Yoo, Eun Jung; Kim, Kyung Ah; Koh, Sun Young; Lee, Yeon Kyung; Shim, Jae Won; Lee, Eun Kyung; Chang, Wook; Kim, Sung Shin; Chang, Yun Sil; Shin, Son Moon

2005-01-01

Newfactan® is a domestically developed, bovine lung-derived, semi-synthetic surfactant. The aim of this study was to compare the clinical efficacy of Newfactan® with that of Surfacten® in the treatment of respiratory distress syndrome (RDS). Newfactan® or Surfacten® was randomly allocated to 492 newborn infants who were diagnosed as RDS and required surfactant instillation in four participating hospitals. The comparisons were made individually in two subsets of infants by birth weight (<1,500 g group [n=253] and ≥1,500 g group [n=239]). Short-term responses to surfactant and acute complications, such as the total doses of surfactant instilled, response type, extubation rate, ventilator settings, changes in respiratory parameters, air leak, patent ductus arteriosus, pulmonary hemorrhage, and intraventricular hemorrhage, and mortality during the 96 hr after surfactant instillation were measured. Long-term outcome and complications, such as total duration of intubation, bronchopulmonary dysplasia and periventricular leukomalacia, and ultimate mortality were measured. There were no significant differences in demographic and perinatal variables, short-term responses to surfactant and acute complications, and long-term outcome and complications between Newfactan® and Surfacten® in both birth weight groups. We concluded that Newfactan® was comparable to Surfacten® in the clinical efficacy in the treatment of RDS in both birth weight groups. PMID:16100449

Dismembered Pyeloplasty in Infants 6 Months Old or Younger With and Without External Trans-anastomotic Nephrostent: A Prospective Randomized Study.

PubMed

Nasser, Farouk M; Shouman, Ahmed M; ElSheemy, Mohammed S; Lotfi, Mohammed A; Aboulela, Waseem; El Ghoneimy, Mohamed; Abdelwahhab, Mohammad; Shoukry, Ahmed I; Ghoneima, Waleed; Morsi, Hany; Badawy, Hesham

2017-03-01

To compare the outcome of dismembered pyeloplasty in infants with and without external nephro-ureteric stent (ENUS) for treatment of congenital ureteropelvic junction obstruction. This is a parallel, randomized comparative study between October 2013 and September 2014. Thirty infants ≤6 months old with ureteropelvic junction obstruction indicated for dismembered pyeloplasty were randomly assigned (block randomization, closed envelope method) into two groups: group A (stentless) and group B (ENUS). Infants with solitary kidney, gross pyuria, huge pelvis, vesicoureteric reflux, or other renal anomalies were excluded. Operative data, complications, and ultrasonographic and nuclear scintigraphy criteria were compared after at least 18 months of follow-up using Student t, Mann-Whitney U, Kruskal-Wallis, chi-square, and Fisher exact tests when appropriate. Occurrence of urinary leakage was the primary outcome. Included patients completed the study with intention-to-treat analysis. All children had normal renal function. The mean operative time was 85.3 ± 6.3 (60-90) minutes in group A and 92.6 ± 15.3 (70-120) minutes in group B (P = .2). Although there was a significant postoperative improvement in each group in split renal function and anterior-posterior renal pelvis diameter, there was no significant difference between both groups. The mean hospital stay for group A and group B was 5.9 ± 2 (4-10) days versus 3.5 ± 0.8 (2-5) days, respectively (P < .001). Postoperative urinary leakage was reported only in group A (40%). All complications were managed by double J insertion. Auxiliary interventions were higher in group A. The overall success rate was 93.4%. Redo pyeloplasty was performed in one case in each group. ENUS significantly reduces hospital stay and complications. It saves the infant hazards of auxiliary interventions under general anesthesia for management of leakage or double J removal if placed at time of pyeloplasty. Copyright �

Growth hormone combined with child-specific motor training improves motor development in infants with Prader-Willi syndrome: a randomized controlled trial.

PubMed

Reus, Linda; Pelzer, Ben J; Otten, Barto J; Siemensma, Elbrich P C; van Alfen-van der Velden, Janielle A A E M; Festen, Dederieke A M; Hokken-Koelega, Anita C S; Nijhuis-van der Sanden, Maria W G

2013-10-01

Although severe motor problems in infants with Prader-Willi syndrome (PWS) are striking, motor development has never been studied longitudinally and the results of growth hormone (GH) treatment on motor development are contradictory. The authors studied whether GH treatment can enhance the effect of physical training on motor development in infants with PWS. Twenty-two infants were followed for two years during a randomized controlled trial. The treatment and control groups began GH after baseline or following a control period, respectively. Both groups followed a child-specific physical training program. Motor performance was measured every three months. Multi-level regression analysis revealed that motor development differed significantly between infants (p<.001), and this could be partially explained by baseline motor developmental level (p<.01). GH treatment enhanced the effects of child-specific physical training on both motor developmental rate and motor developmental potential. Moreover, this effect was more pronounced when GH treatment was initiated at a younger age. Copyright © 2013 Elsevier Ltd. All rights reserved.

Disparities in infant mortality and effective, equitable care: are infants suffering from benign neglect?

PubMed

Rowley, Diane L; Hogan, Vijaya

2012-04-01

Quality care for infant mortality disparity elimination requires services that improve health status at both the individual and the population level. We examine disparity reduction due to effective care and ask the following question: Has clinical care ameliorated factors that make some populations more likely to have higher rates of infant mortality compared with other populations? Disparities in postneonatal mortality due to birth defects have emerged for non-Hispanic black and Hispanic infants. Surfactant and antenatal steroid therapy have been accompanied by growing disparities in respiratory distress syndrome mortality for black infants. Progesterone therapy has not reduced early preterm birth, the major contributor to mortality disparities among non-Hispanic black and Puerto Rican infants. The Back to Sleep campaign has minimally reduced SIDS disparities among American Indian/Alaska Native infants, but it has not reduced disparities among non-Hispanic black infants. In general, clinical care is not equitable and contributes to increasing disparities.

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial

PubMed Central

Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-01-01

Background Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. Objective The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. Methods The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List–Short Form, Maternal Support Scale, Ages and Stages Questionnaire–Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Results Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

PubMed

Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-07-24

Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of

Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.

PubMed

Davis, Stephanie D; Ratjen, Felix; Brumback, Lyndia C; Johnson, Robin C; Filbrun, Amy G; Kerby, Gwendolyn S; Panitch, Howard B; Donaldson, Scott H; Rosenfeld, Margaret

2016-05-01

The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint. Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials. Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0). iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Influence of Clinical Status on the Association Between Plasma Total and Unbound Bilirubin and Death or Adverse Neurodevelopmental Outcomes in Extremely Low Birth Weight Infants

PubMed Central

Oh, William; Stevenson, David K.; Tyson, Jon E.; Morris, Brenda H.; Ahlfors, Charles E.; Bender, G. Jesse; Wong, Ronald J.; Perritt, Rebecca; Vohr, Betty R.; Van Meurs, Krista P.; Vreman, Hendrik J.; Das, Abhik; Phelps, Dale L.; O’Shea, T. Michael; Higgins, Rosemary D.

2010-01-01

Objectives To assess the influence of clinical status on the association between total plasma bilirubin and unbound bilirubin on death or adverse neurodevelopmental outcomes at 18–22 months corrected age in extremely low birth weight infants. Method Total plasma biirubin and unbound biirubin were measured in 1,101 extremely low birth weight infants at 5±1 day of age. Clinical criteria were used to classify infants as clinically stable or unstable. Survivors were examined at 18–22 months corrected age by certified examiners. Outcome variables were death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death prior to follow-up. For all outcomes, the interaction between bilirubin variables and clinical status was assessed in logistic regression analyses adjusted for multiple risk factors. Results Regardless of clinical status, an increasing level of unbound bilirubin was associated with higher rates of death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss and death before follow-up. Total plasma bilirubin values were directly associated with death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death before follow-up in unstable infants, but not in stable infants. An inverse association between total plasma bilirubin and death or cerebral palsy was found in stable infants. Conclusions In extremely low birth weight infants, clinical status at 5 days of age affects the association between total plasma and unbound bilirubin and death or adverse neurodevelopmental outcomes at 18–22 months of corrected age. An increasing level of UB is associated a higher risk of death or adverse neurodevelopmental outcomes regardless of clinical status. Increasing levels of total plasma bilirubin are directly associated with increasing risk of death or adverse neurodevelopmental outcomes in unstable, but not in stable infants. PMID:20105142

Affective facial expression in sub-clinically depressed and non-depressed mothers during contingent and non-contingent face-to-face interactions with their infants.

PubMed

Braarud, Hanne Cecilie; Skotheim, Siv; Høie, Kjartan; Markhus, Maria Wik; Kjellevold, Marian; Graff, Ingvild Eide; Berle, Jan Øystein; Stormark, Kjell Morten

2017-08-01

Depression in the postpartum period involves feelings of sadness, anxiety and irritability, and attenuated feelings of pleasure and comfort with the infant. Even mild- to- moderate symptoms of depression seem to have an impact on caregivers affective availability and contingent responsiveness. The aim of the present study was to investigate non-depressed and sub-clinically depressed mothers interest and affective expression during contingent and non-contingent face-to-face interaction with their infant. The study utilized a double video (DV) set-up. The mother and the infant were presented with live real-time video sequences, which allowed for mutually responsive interaction between the mother and the infant (Live contingent sequences), or replay sequences where the interaction was set out of phase (Replay non-contingent sequences). The DV set-up consisted of five sequences: Live1-Replay1-Live2-Replay2-Live3. Based on their scores on the Edinburgh Postnatal Depression Scale (EPDS), the mothers were divided into a non-depressed and a sub-clinically depressed group (EPDS score≥6). A three-way split-plot ANOVA showed that the sub-clinically depressed mothers displayed the same amount of positive and negative facial affect independent of the quality of the interaction with the infants. The non-depressed mothers displayed more positive facial affect during the non-contingent than the contingent interaction sequences, while there was no such effect for negative facial affect. The results indicate that sub-clinically level depressive symptoms influence the mothers' affective facial expression during early face-to-face interaction with their infants. One of the clinical implications is to consider even sub-clinical depressive symptoms as a risk factor for mother-infant relationship disturbances. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Hyperparasitaemia during clinical malaria episodes in infants aged 0-24 months and its association with in utero exposure to Plasmodium falciparum.

PubMed

Sylvester, Boniphace; Gasarasi, Dinah B; Aboud, Said; Tarimo, Donath; Massawe, Siriel; Mpembeni, Rose; Swedberg, Gote

2018-04-04

Existing information has shown that infants who are prenatally exposed to P. falciparum are susceptible to subsequent malaria infections. However, the effect of prenatal exposure to P. falciparum on parasite density during clinical malaria episodes has not been fully elucidated. This study is a component of a prospective cohort study for which initial results have been published. This component was designed to determine the effect of prenatal exposure to P. falciparum on parasite density during clinical malaria episodes in the first 24 months of life. A total of 215 infants were involved and monitored for clinical malaria episodes defined by fever (≥ 37 °C) and parasitaemia. The geometric mean parasite counts between exposed and unexposed infants were compared using independent samples t test. The effect of in utero exposure to P. falciparum on parasite density was assessed using binary logistic regression. The geometric mean parasite count per µl of blood during clinical malaria episodes in exposed infants was 24,889 (95% CI 18,286-31,490) while in unexposed infants it was 14,035 (95% CI 12,111-15,960), P < 0.05. Prenatal exposure to P. falciparum was associated with hyperparasitaemia during clinical malaria episodes (OR 7.04, 95% CI 2.31-21.74), while other factors were not significantly associated (P > 0.05).

Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.

PubMed

Dotres, Carlos P; Puga, Rinaldo; Ricardo, Yariset; Broño, Carmen R; Paredes, Beatriz; Echemendía, Vladimir; Rosell, Sandra; González, Nadezhda; García-Rivera, Dagmar; Valdés, Yury; Goldblatt, David; Vérez-Bencomo, Vicente

2014-09-15

A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial.

PubMed

Alshweki, Ayham; Muñuzuri, Alejandro Pérez; Baña, Ana M; de Castro, Ma José; Andrade, Fernando; Aldamiz-Echevarría, Luís; de Pipaón, Miguel Sáenz; Fraga, José M; Couce, María L

2015-09-30

Nutritional supplementation with polyunsaturated fatty acids is important in preterm infants neurodevelopment, but it is not known if the omega-6/omega-3 ratio affects this process. This study was designed to determine the effects of a balanced contribution of arachidonic acid in very preterm newborns fed with formula milk. This was a randomized trial, in which newborns <1500 g and/or <32 weeks gestational age were assigned to one of two groups, based on the milk formula they would receive during the first year of life. Initially, 60 newborns entered the study, but ultimately, group A was composed of 24 newborns, who were given formula milk with an ω-6/ω-3 ratio of 2/1, and Group B was composed of 21 newborns, given formula milk with an ω-6/ω-3 ratio of 1/1. The infants were followed up for two years: growth, visual-evoked potentials, brainstem auditory-evoked potentials, and plasma fatty acids were periodically measured, and psychomotor development was assessed using the Brunet Lézine scale at 24 months corrected age. A control group, for comparison of Brunet Lézine score, was made up of 25 newborns from the SEN1500 project, who were fed exclusively with breast milk. At 12 months, arachidonic acid values were significantly higher in group A than in group B (6.95 ± 1.55% vs. 4.55 ± 0.78%), as were polyunsaturated fatty acids (41.02 ± 2.09% vs. 38.08 ± 2.32%) achieved a higher average. Group A achieved a higher average Brunet Lézine score at 24 months than group B (99.9 ± 9 vs. 90.8 ± 11, p =0.028). The Brunet Lézine results from group A were compared with the control group results, with very similar scores registered between the two groups (99.9 ± 9 vs. 100.5 ± 7). There were no significant differences in growth or evoked potentials between the two formula groups. Very preterm infants who received formula with an ω-6/ω-3 ratio of 2/1 had higher blood levels of essential fatty acids during the first year of life, and better psychomotor development

Clinical and laboratory features of urinary tract infections in young infants.

PubMed

Lo, Denise Swei; Rodrigues, Larissa; Koch, Vera Hermina Kalika; Gilio, Alfredo Elias

2018-04-26

Urinary tract infection (UTI) is the most common serious bacterial infection in young infants. Signs and symptoms are often nonspecific. To describe clinical, demographic and laboratory features of UTI in infants ≤ 3 months old. Cross-sectional study of infants ≤ 3 months old with UTI diagnosed in a pediatric emergency department, for the period 2010-2012. UTI was defined as ≥ 50,000 colony-forming units per milliliter of a single uropathogen isolated from bladder catheterization. Paired urinalysis and urine culture from group culture-positive and group culture-negative were used to determine the sensitivity and specificity of pyuria and nitrite tests in detecting UTI. Of 519 urine cultures collected, UTI was diagnosed in 65 cases (prevalence: 12.5%); with male predominance (77%). The most common etiologies were Escherichia coli (56.9%), Klebsiella pneumoniae (18.5%) and Enterococcus faecalis (7.7%). Frequent clinical manifestations were fever (77.8%), irritability (41.4%) and vomiting (25.4%). The median temperature was 38.7°C. The sensitivity of the nitrite test was 30.8% (95%CI:19.9-43.4%), specificity of 100% (95%CI:99.2-100%). Pyuria ≥ 10,000/mL had a sensitivity of 87.7% (95%CI:77.2-94.5%), specificity of 74.9% (95%CI:70.6 -78.8%). The median peripheral white blood cell count was 13,150/mm3; C-reactive protein levels were normal in 30.5% of cases. The male: female ratio for urinary tract infection was 3.3:1. Non-Escherichia coli etiologies should be considered in empirical treatment. Fever was the main symptom. Positive nitrite is highly suggestive of UTI but has low sensitivity; whereas pyuria ≥ 10,000/mL revealed good sensitivity, but low specificity. Peripheral white blood cell count and C-reactive protein concentration have limited usefulness to suggest UTI.

Clinical and laboratory features of urinary tract infections in young infants.

PubMed

Lo, Denise Swei; Rodrigues, Larissa; Koch, Vera Hermina Kalika; Gilio, Alfredo Elias

2018-01-01

Urinary tract infection (UTI) is the most common serious bacterial infection in young infants. Signs and symptoms are often nonspecific. To describe clinical, demographic and laboratory features of UTI in infants ≤ 3 months old. Cross-sectional study of infants ≤ 3 months old with UTI diagnosed in a pediatric emergency department, for the period 2010-2012. UTI was defined as ≥ 50,000 colony-forming units per milliliter of a single uropathogen isolated from bladder catheterization. Paired urinalysis and urine culture from group culture-positive and group culture-negative were used to determine the sensitivity and specificity of pyuria and nitrite tests in detecting UTI. Of 519 urine cultures collected, UTI was diagnosed in 65 cases (prevalence: 12.5%); with male predominance (77%). The most common etiologies were Escherichia coli (56.9%), Klebsiella pneumoniae (18.5%) and Enterococcus faecalis (7.7%). Frequent clinical manifestations were fever (77.8%), irritability (41.4%) and vomiting (25.4%). The median temperature was 38.7°C. The sensitivity of the nitrite test was 30.8% (95%CI:19.9-43.4%), specificity of 100% (95%CI:99.2-100%). Pyuria ≥ 10,000/mL had a sensitivity of 87.7% (95%CI:77.2-94.5%), specificity of 74.9% (95%CI:70.6 -78.8%). The median peripheral white blood cell count was 13,150/mm3; C-reactive protein levels were normal in 30.5% of cases. The male: female ratio for urinary tract infection was 3.3:1. Non-Escherichia coli etiologies should be considered in empirical treatment. Fever was the main symptom. Positive nitrite is highly suggestive of UTI but has low sensitivity; whereas pyuria ≥ 10,000/mL revealed good sensitivity, but low specificity. Peripheral white blood cell count and C-reactive protein concentration have limited usefulness to suggest UTI.

Maternal Attachment Behaviors with Adopted and Birth Infants.

ERIC Educational Resources Information Center

Chan, Marilyn M.

This study investigated: (1) effects of teaching mothers the unique behavioral cues of their adopted infants and (2) potential differences between the mothering practices of adoptive and birth mothers. A pretest, posttest experimental prospective design was used with random assignment of mother-infant dyads. Mother-adopted infant dyads were…

Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial

PubMed Central

Thanathanee, Onsiri; Ratanapakorn, Tanapat; Morley, Michael G; Yospaiboon, Yosanan

2012-01-01

Objective To compare the mydriatic effect of lower conjunctival fornix packing to conventional instillation of eyedrops containing 2.5% phenylephrine and 1% tropicamide in premature infants undergoing examination for retinopathy of prematurity. Methods The patients were randomized to receive either conventional instillation of mydriatic drops or lower conjunctival fornix packing in one eye and the alternate method in the fellow eye. For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix for 15 minutes. For the eyes receiving the conventional instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each. Horizontal pupil diameter was measured with a ruler in millimeters 40 minutes later. Results The mean dilated pupil diameter in study group and control group were 5.76 ± 1.01 mm and 4.50 ± 1.08 mm, respectively. This difference was statistically significant (P < 0.05). Conclusion The dilated pupil diameter after receiving the lower conjunctival fornix packing was larger than conventional instillation with a statistically significant difference. We recommended the packing method to dilate the preterm infant pupil, especially if the pupil is difficult to dilate. PMID:22368443

Infant feeding and infant health in American Samoa.

PubMed

Bindon, James R; Cabrera-Mereb, Claudine

1990-01-01

This study examines the association between infant feeding patterns and health for 6,267 Samoan children born between 1976 and 1982, and represented in the Well Baby Clinic records at the LBJ Tropical Medical Center, American Samoa. The visits to the clinic were aggregated by trimester of age during the first year of life. For each trimester, the principal source of milk was determined, and the children were categorized as breast-fed if they were taking only breast milk, bottle-fed if they were getting no breast milk, or mixed-fed if they were getting both breast milk and milk from other sources. Symptoms and complaints noted in the records were assigned to ICD categories. Associations between source of milk and disease category were analyzed. The Samoan infants were found to be quite healthy for a tropical developing population, as evidenced by both growth in weight and length, as well as by frequency of illnesses. The most common specific disease category, aside from miscellaneous symptoms, was ICD 8, respiratory problems. Gastrointestinal diseases were rare for a developing area. There was an association between source of milk and illness (yes/no) for both the second and third trimesters. In both cases breast-fed infants were healthier than the mixed-fed infants, and during the second trimester the contrast was significant with bottle-fed infants also. When examined by ICD category, breast-fed infants tended to be less likely to have problems in any of the categories, but the only significant differences were between mixed-fed (lower prevalence) and bottle-fed infants during the first trimester for ICD 3, primarily nutritional problems; and for breast-fed (lower prevalence) and mixed-fed infants for ICD 9, digestive problems. These findings highlight the need for additional household work to delineate associations with the growth and health of Samoan infants. Copyright © 1990 Wiley-Liss, Inc., A Wiley Company.

Infant Feeding among Women Attending an Immunisation Clinic at a Tertiary Health Institution in Ibadan, Nigeria

ERIC Educational Resources Information Center

Fatiregun, A. A.; Abegunde, V. O.

2009-01-01

Maternal characteristics can affect a mother's decision to breastfeed. This study used a cross-sectional design to assess maternal variables and infant feeding patterns among nursing mothers attending an immunisation clinic in Ibadan, Nigeria. A total of 264 mothers who consecutively attended the immunisation clinic and met certain inclusion…

Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination: A Phase 3 Randomized, Controlled Trial in Children and Young Infants at 11 African Sites

PubMed Central

2014-01-01

Background A malaria vaccine could be an important addition to current control strategies. We report the safety and vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission. Methods and Findings 6,537 infants aged 6–12 wk and 8,923 children aged 5–17 mo were randomized to receive three doses of RTS,S/AS01 or comparator vaccine. VE against clinical malaria in children during the 18 mo after vaccine dose 3 (per protocol) was 46% (95% CI 42% to 50%) (range 40% to 77%; VE, p<0.01 across all sites). VE during the 20 mo after vaccine dose 1 (intention to treat [ITT]) was 45% (95% CI 41% to 49%). VE against severe malaria, malaria hospitalization, and all-cause hospitalization was 34% (95% CI 15% to 48%), 41% (95% CI 30% to 50%), and 19% (95% CI 11% to 27%), respectively (ITT). VE against clinical malaria in infants was 27% (95% CI 20% to 32%, per protocol; 27% [95% CI 21% to 33%], ITT), with no significant protection against severe malaria, malaria hospitalization, or all-cause hospitalization. Post-vaccination anti-circumsporozoite antibody geometric mean titer varied from 348 to 787 EU/ml across sites in children and from 117 to 335 EU/ml in infants (per protocol). VE waned over time in both age categories (Schoenfeld residuals p<0.001). The number of clinical and severe malaria cases averted per 1,000 children vaccinated ranged across sites from 37 to 2,365 and from −1 to 49, respectively; corresponding ranges among infants were −10 to 1,402 and −13 to 37, respectively (ITT). Meningitis was reported as a serious adverse event in 16/5,949 and 1/2,974 children and in 9/4,358 and 3/2,179 infants in the RTS,S/AS01 and control groups, respectively. Conclusions RTS,S/AS01 prevented many cases of clinical and severe malaria over the 18 mo after vaccine dose 3, with the highest impact in areas with the greatest malaria incidence. VE was higher in children than in infants, but even at

Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT).

PubMed

Kingston, Dawn; Austin, Marie-Paule; Hegadoren, Kathy; McDonald, Sheila; Lasiuk, Gerri; McDonald, Sarah; Heaman, Maureen; Biringer, Anne; Sword, Wendy; Giallo, Rebecca; Patel, Tejal; Lane-Smith, Marie; van Zanten, Sander Veldhuyzen

2014-03-06

Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and

Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

PubMed Central

2014-01-01

Background Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. Methods/Design The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum

Inhaled Nitric Oxide Therapy for Pulmonary Disorders of the Term and Preterm Infant

PubMed Central

Sokol, Gregory M.; Konduri, G. Ganesh; Van Meurs, Krisa P.

2016-01-01

The 21st century began with the FDA approval of inhaled nitric oxide therapy for the treatment of neonatal hypoxic respiratory failure associated with pulmonary hypertension in recognition of the two randomized clinical trials demostrating a significant reduction in the need for extracorporeal support in the term and near-term infant. Inhaled nitric oxide is one of only a few therapeutic agents approved for use through clinical investigations primarily in the neonate. This article provides an overview of the pertinent biology and chemistry of nitric oxide, discusses potential toxicities, and reviews the results of pertinent clinical investigations and large randomized clinical trials including neurodevelopmental follow-up in term and preterm neonates. The clinical investigations conducted by the Eunice Kennedy Shriver NICHD Neonatal Research Network will be discussed and placed in context with other pertinent clinical investigations exploring the efficacy of inhaled nitric oxide therapy in neonatal hypoxic respiratory failure. PMID:27480246

Probiotic Supplementation in Preterm Infants Does Not Affect the Risk of Bronchopulmonary Dysplasia: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Mosca, Fabio; Kramer, Boris

2017-01-01

Probiotic supplementation reduces the risk of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) in preterm infants, but it remains to be determined whether this reduction translates into a reduction of other complications. We conducted a systematic review and meta-analysis to evaluate the possible role of probiotics in altering the risk of bronchopulmonary dysplasia (BPD). Fifteen randomized controlled trials (4782 infants; probiotics: 2406) were included. None of the included studies assessed BPD as the primary outcome. Meta-analysis confirmed a significant reduction of NEC (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.33 to 0.81, p = 0.004; random effects model), and an almost significant reduction of LOS (RR 0.82, 95% CI 0.65 to 1.03, p = 0.084). In contrast, meta-analysis could not demonstrate a significant effect of probiotics on BPD, defined either as oxygen dependency at 28 days of life (RR 1.01, 95% CI 0.91 to 1.11, p = 0.900, 6 studies) or at 36 weeks of postmenstrual age (RR 1.07, 95% CI 0.96 to 1.20, p = 0.203, 12 studies). Meta-regression did not show any significant association between the RR for NEC or LOS and the RR for BPD. In conclusion, our results suggest that NEC and LOS prevention by probiotics does not affect the risk of developing BPD in preterm infants. PMID:29088103

High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study).

PubMed

Milési, Christophe; Essouri, Sandrine; Pouyau, Robin; Liet, Jean-Michel; Afanetti, Mickael; Portefaix, Aurélie; Baleine, Julien; Durand, Sabine; Combes, Clémentine; Douillard, Aymeric; Cambonie, Gilles

2017-02-01

Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants. A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH 2 O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events. From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of -19% (95% CI -35 to -3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02-2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died. In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).

Prevalence of otitis media and risk-factors for sensorineural hearing loss among infants attending Child Welfare Clinics in the Solomon Islands.

PubMed

Kaspar, Annette; Newton, Obiga; Kei, Joseph; Driscoll, Carlie; Swanepoel, De Wet; Goulios, Helen

2018-08-01

The present study aimed to assess the prevalence of otitis media and risk-factors for sensorineural hearing loss among infants in the Solomon Islands, in order to recommend an Infant Ear and Hearing Program that would be suitable to the Pacific Island context. Ear examinations and the JCIH Risk-Factor Questionnaire were administered to 288 infants attending Child Welfare Clinics in the Solomon Islands. Overall, 150 infants (52.084%) presented with bilateral normal ear examinations and no risk-factors for SNHL. There were 73 infants (25.34%) with ear pathology in at least one ear, 13 (4.5%) of whom required referral to the ENT Clinic for medical management. The most common pathology was otitis media with effusion (OME) (21.87%). Infants aged 7-12 months were significantly more likely to present with OME (p<0.001) and a history of otitis media (p=0.017) than infants aged 0-6 months. There were 71 infants (24.65%) with at least one risk-factor for sensorineural hearing loss. The most common risk-factors were ototoxicity (8.3%), non-elective caesarean delivery (6.59%), and possible in-utero syphilis infection (5.55%). The prevalence of otitis media and risk-factors for sensorineural hearing loss indicate the importance of initiating Infant Ear and Hearing Programs in the Solomon Islands. Program should facilitate early education on prevention of ear disease, as well as early diagnosis and management of children with hearing loss. Copyright © 2018. Published by Elsevier B.V.

Simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplified Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial.

PubMed

Mir, Fatima; Nisar, Imran; Tikmani, Shiyam S; Baloch, Benazir; Shakoor, Sadia; Jehan, Fyezah; Ahmed, Imran; Cousens, Simon; Zaidi, Anita K M

2017-02-01

Parenteral antibiotic therapy for young infants (aged 0-59 days) with suspected sepsis is sometimes not available or feasible in countries with high neonatal mortality. Outpatient treatment could save lives in such settings. We aimed to assess the equivalence of two simplified antibiotic regimens, comprising fewer injections and oral rather than parenteral administration, compared with a reference treatment for young infants with clinical severe infection. We undertook the Simplified Antibiotic Therapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in five communities in Karachi, Pakistan. We enrolled young infants (aged 0-59 days) who either presented at a primary health-care clinic or were identified by a community health worker with signs of clinical severe infection. We included infants who were not critically ill and whose family refused admission. We randomly assigned infants to either intramuscular procaine benzylpenicillin and gentamicin once a day for 7 days (reference); oral amoxicillin twice daily and intramuscular gentamicin once a day for 7 days; or intramuscular procaine benzylpenicillin and gentamicin once a day for 2 days followed by oral amoxicillin twice daily for 5 days. The primary outcome was treatment failure within 7 days of enrolment and the primary analysis was per protocol. We judged experimental treatments as efficacious as the reference if the upper bound of the 95% CI for the difference in treatment failure was less than 5·0. This trial is registered at ClinicalTrials.gov, number NCT01027429. Between Jan 1, 2010, and Dec 26, 2013, 2780 infants were deemed eligible for the trial, of whom 2453 (88%) were enrolled. Because of inadequate clinical follow-up or treatment adherence, 2251 infants were included in the per-protocol analysis. 820 infants (747 per protocol) were assigned the reference treatment of procaine benzylpenicillin and gentamicin, 816 (751 per protocol) were allocated amoxicillin and gentamicin, and

The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial.

PubMed

Strand, Tor A; Ulak, Manjeswori; Chandyo, Ram K; Kvestad, Ingrid; Hysing, Mari; Shrestha, Merina; Basnet, Sudha; Ranjitkar, Suman; Shrestha, Laxman; Shrestha, Prakash S

2017-04-21

Vitamin B 12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B 12 is crucial for normal cell division and differentiation, and it is necessary for the development and myelination of the central nervous system. The aim of the present study is to measure the effect of daily supplementation of vitamin B 12 on the neurodevelopment and growth of young children in Nepal. We are conducting an individually randomized, double-blind, placebo-controlled trial with 600 marginally stunted children 6-11 months old (length for age less than -1 z-score). Children are randomized to receive a lipid-based paste containing vitamin B 12 or placebo daily for 12 months. The main outcomes are changes in growth (z-scores) and in neurodevelopment measured by the Bayley Scales of Infant and Toddler Development, Third Edition, from baseline until the end of the study. If vitamin B 12 supplementation benefits early child development and growth, this will have consequences for dietary recommendations for malnourished children worldwide. ClinicalTrials.gov Identifier: NCT02272842 . Registered on 21 October 2014. Universal Trial Number: U1111-1161-5187. Registered on 8 September 2014.

The effect of massage on neonatal jaundice in stable preterm newborn infants: a randomized controlled trial.

PubMed

Basiri-Moghadam, Mahdi; Basiri-Moghadam, Kokab; Kianmehr, Mojtaba; Jani, Somaye

2015-06-01

To evaluate the effects of massage therapy on transcutaneous bilirubin of stable preterm infants. The controlled clinical trial was conducted in 2014 at Shahid Hasheminejhad Hospital, Iran, and comprised preterm neonatal children in the neonatal intensive care unit. The newborns were divided into two groups of massage and control via random allocation. The children in the control group received the routine therapy whereas those in the massage group underwent the same four days of routine plus 20 minutes of massage twice a day. The transcutaneous bilirubin and the number of excretions of the newborns were noted from the first to the fourth day of the intervention and results were compared between the two groups. There were 40 newborns in the study l 20(50%) each in the two groups. There was a significant difference in the number of times of defecation (p=0.002) and in the level of bilirubin (p=0.003) between the groups with those in the massage group having a higher number of defecations as well as a lower level of transcutaneous bilirubin. Through massage therapy the bilirubin level in preterm newborns can be controlled and a need for phototherapy can also be delayed.

[Clinical research of Bordetella pertussis infection in infants with prolonged cough].

PubMed

Mi, Rong; Fu, Jin; Wang, Xiao-ying; Kang, Li-min; Li, Li; Xu, Fang-sheng; Cui, Xiao-dai

2013-06-11

To explore the prevalence of Bordetella pertussis (B. pertussis) infection in unvaccinated or incomplete vaccinated infants with cough for a prolonged duration. The serum samples and nasopharyngeal secretions were collected from 176 patients with cough for a prolonged duration ( ≥ 2 weeks) from 2011 to 2012 at Children's Hospital Affiliated to Capital Institute of Pediatrics. Multiplex PCR of nasopharyngeal secretion was employed to identify B.pertussis. And enzyme-linked immunosorbent assay(ELISA) was used to detect antibody to pertussis toxin(PT-IgG). Total bacterial DNA was enacted from nasopharyngeal secretion and two-target IS481/PT of B.pertussis was detected by PCR. The sera and nasopharyngeal secretions were also collected from household contacts with cough for a prolonged duration. Their clinical characteristic and epidemiological profiles were collected and analyzed. B.Pertussis infection was demonstrated in 51 cases (29.0%). The patients ages were from 23 days to 4 years. Among them, 46 cases (90.2%) were aged under 12 months and 5 cases (9.8%) over 12 months. And 40 cases were unvaccinated (31 cases <3 months old, 4 cases 3-12 months old, 5 cases >5 years old) and 11 cases incompletely vaccinated. There were 31 males and 20 females. More patients were found in spring and summer than those in autumn and winter. Nine infant cases had 12 household contacts. Among 12 household contacts, 3 were PCR positive and 12 PT-IgG positive. Pertussis was remarkably critical in infants. Serious complications included failure to thrive, pneumonia, respiratory failure and seizures. B.pertussis infection is an important cause in unvaccinated or incomplete vaccinated infants with prolonged cough. Peak seasons of pertussis are spring and summer. Undiagnosed adolescents and adults with pertussis may be a significant source for transmission of B.pertussis to other susceptible children. Infants aged under 1 year are at risk for severe pertussis and life

Point Prevalence, Clinical Characteristics, and Treatment Variation for Infants with Severe Bronchopulmonary Dysplasia

PubMed Central

Guaman, Milenka Cuevas; Gien, Jason; Baker, Christopher D.; Zhang, Huayan; Austin, Eric D.; Collaco, Joseph M.

2015-01-01

Objectives Despite improvements in survival of preterm infants, bronchopulmonary dysplasia (BPD) remains a persistent morbidity. The incidence, clinical course, and current management of severe BPD (sBPD) remain to be defined. To address these knowledge gaps, a multicenter collaborative was formed to improve outcomes in this population. Study Design We performed a “snapshot” in eight neonatal intensive care units (NICUs) on December 17, 2013. A standardized clinical data form for each inpatient born at < 32 weeks was completed and collated centrally for analysis. sBPD was defined as receiving ≥ 30% supplemental oxygen and/or receiving positive pressure ventilation at 36 weeks postmenstrual age (PMA). Results Of a total census of 710 inpatients, 351 infants were born at < 32 weeks and 128 of those (36.5%) met criteria for sBPD. The point prevalence of sBPD varied between centers (11–58%; p < 0.001). Among infants with sBPD there was a variation among centers in the use of mechanical ventilation at 28 days of life (p < 0.001) and at 36 weeks PMA (p = 0.001). We observed differences in the use of diuretics (p = 0.018), inhaled corticosteroids (p < 0.001), and inhaled β-agonists (p < 0.001). Conclusion The high point prevalence of sBPD and variable management among NICUs emphasizes the lack of evidence in guiding optimal care to improve long-term outcomes of this high-risk, understudied population. PMID:25738785

Clinical course of asymmetric motor performance and deformational plagiocephaly in very preterm infants.

PubMed

Nuysink, Jacqueline; Eijsermans, Maria J C; van Haastert, Ingrid C; Koopman-Esseboom, Corine; Helders, Paul J M; de Vries, Linda S; van der Net, Janjaap

2013-09-01

To describe the clinical courses of positional preference and deformational plagiocephaly up to 6 months corrected age (CA) in infants born at gestational age <30 weeks or birth weight <1000 g, and to explore predictive factors for the persistence of these phenomena. A total of 120 infants were examined 3 times each. The presence of deformational plagiocephaly and a score of 0-6 on an asymmetry performance scale served as outcome measures at 6 months CA. Predictive factors were determined using regression analysis. The prevalence of a positional preference of the head was 65.8% (79 of 120) at term-equivalent age (TEA) and 36.7% (44 of 120) at 3 months CA and that of deformational plagiocephaly was 30% (36 of 120) at TEA and 50% (60 of 120) at 3 months CA. At 6 months CA, 15.8% of the infants (19 of 120) scored ≥ 2 of a possible 6 on the asymmetry performance scale and 23.3% (28 of 120) had deformational plagiocephaly. Sleeping in the supine position was predictive of an asymmetric motor performance at 6 months CA. Chronic lung disease and/or slow gross motor maturation at 3 months CA predicted the persistence of deformational plagiocephaly. Infants born very preterm may develop deformational plagiocephaly. A positional preference of the head at TEA seems to be a normal aspect of these infants' motor repertoire, with limited ability to predict persistence of an asymmetric motor performance. The decreased prevalence of deformational plagiocephaly between 3 and 6 months CA indicates an optimistic course. Infants with a history of chronic lung disease and/or slow gross motor maturation merit timely intervention. Copyright © 2013 Mosby, Inc. All rights reserved.

Impact of a Modified Version of Baby-Led Weaning on Infant Food and Nutrient Intakes: The BLISS Randomized Controlled Trial.

PubMed

Williams Erickson, Liz; Taylor, Rachael W; Haszard, Jillian J; Fleming, Elizabeth A; Daniels, Lisa; Morison, Brittany J; Leong, Claudia; Fangupo, Louise J; Wheeler, Benjamin J; Taylor, Barry J; Te Morenga, Lisa; McLean, Rachael M; Heath, Anne-Louise M

2018-06-07

Despite growing international interest in Baby-Led Weaning (BLW), we know almost nothing about food and nutrient intake in infants following baby-led approaches to infant feeding. The aim of this paper was to determine the impact of modified BLW (i.e., Baby-Led Introduction to SolidS; BLISS) on food and nutrient intake at 7⁻24 months of age. Two hundred and six women recruited in late pregnancy were randomized to Control ( n = 101) or BLISS ( n = 105) groups. All participants received standard well-child care. BLISS participants also received lactation consultant support to six months, and educational sessions about BLISS (5.5, 7, and 9 months). Three-day weighed diet records were collected for the infants (7, 12, and 24 months). Compared to the Control group, BLISS infants consumed more sodium (percent difference, 95% CI: 35%, 19% to 54%) and fat (6%, 1% to 11%) at 7 months, and less saturated fat (-7%, -14% to -0.4%) at 12 months. No differences were apparent at 24 months of age but the majority of infants from both groups had excessive intakes of sodium (68% of children) and added sugars (75% of children). Overall, BLISS appears to result in a diet that is as nutritionally adequate as traditional spoon-feeding, and may address some concerns about the nutritional adequacy of unmodified BLW. However, BLISS and Control infants both had high intakes of sodium and added sugars by 24 months that are concerning.

Breastfeeding Progression in Preterm Infants Is Influenced by Factors in Infants, Mothers and Clinical Practice: The Results of a National Cohort Study with High Breastfeeding Initiation Rates

PubMed Central

Maastrup, Ragnhild; Hansen, Bo Moelholm; Kronborg, Hanne; Bojesen, Susanne Norby; Hallum, Karin; Frandsen, Annemi; Kyhnaeb, Anne; Svarer, Inge; Hallström, Inger

2014-01-01

Background and Aim Many preterm infants are not capable of exclusive breastfeeding from birth. To guide mothers in breastfeeding, it is important to know when preterm infants can initiate breastfeeding and progress. The aim was to analyse postmenstrual age (PMA) at breastfeeding milestones in different preterm gestational age (GA) groups, to describe rates of breastfeeding duration at pre-defined times, as well as analyse factors associated with PMA at the establishment of exclusive breastfeeding. Methods The study was part of a prospective survey of a national Danish cohort of preterm infants based on questionnaires and structured telephone interviews, including 1,221 mothers and their 1,488 preterm infants with GA of 24–36 weeks. Results Of the preterm infants, 99% initiated breastfeeding and 68% were discharged exclusively breastfed. Breastfeeding milestones were generally reached at different PMAs for different GA groups, but preterm infants were able to initiate breastfeeding at early times, with some delay in infants less than GA 32 weeks. Very preterm infants had lowest mean PMA (35.5 weeks) at first complete breastfeed, and moderate preterm infants had lowest mean PMA at the establishment of exclusive breastfeeding (36.4 weeks). Admitting mothers to the NICU together with the infant and minimising the use of a pacifier during breastfeeding transition were associated with 1.6 (95% CI 0.4–2.8) and 1.2 days (95% CI 0.1–2.3) earlier establishment of exclusive breastfeeding respectively. Infants that were small for gestational age were associated with 5.6 days (95% CI 4.1–7.0) later establishment of exclusive breastfeeding. Conclusion Breastfeeding competence is not developed at a fixed PMA, but is influenced by multiple factors in infants, mothers and clinical practice. Admitting mothers together with their infants to the NICU and minimising the use of pacifiers may contribute to earlier establishment of exclusive breastfeeding. PMID:25251690

Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT.

PubMed

Chidini, Giovanna; Piastra, Marco; Marchesi, Tiziana; De Luca, Daniele; Napolitano, Luisa; Salvo, Ida; Wolfler, Andrea; Pelosi, Paolo; Damasco, Mirco; Conti, Giorgio; Calderini, Edoardo

2015-04-01

Noninvasive continuous positive airway pressure (CPAP) is usually applied with a nasal or facial mask to treat mild acute respiratory failure (ARF) in infants. A pediatric helmet has now been introduced in clinical practice to deliver CPAP. This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF. In this multicenter randomized controlled trial, 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet (n = 17) or facial mask (n = 13). The primary endpoint was treatment failure rate (defined as due to intolerance or need for intubation). Secondary outcomes were CPAP application time, number of patients requiring sedation, and complications with each interface. Compared with the facial mask, CPAP by helmet had a lower treatment failure rate due to intolerance (3/17 [17%] vs 7/13 [54%], P = .009), and fewer infants required sedation (6/17 [35%] vs 13/13 [100%], P = .023); the intubation rates were similar. In successfully treated patients, CPAP resulted in better gas exchange and breathing pattern with both interfaces. No major complications due to the interfaces occurred, but CPAP by mask had higher rates of cutaneous sores and leaks. These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation. In addition, it is safe to use and free from adverse events, even in a prolonged clinical setting. Copyright © 2015 by the American Academy of Pediatrics.

The Infant Parent Training Institute: A Developmental Model for Training Infant Mental Health Professionals

ERIC Educational Resources Information Center

Arons, Judith; Epstein, Ann; Sklan, Susan

2011-01-01

The Infant Parent Training Institute (IPTI) at Jewish Family and Children's Service of Greater Boston offers integrated clinical and theoretical infant mental health training. The curriculum reflects the belief that nurturing and reflective relationships promote optimal learning and growth. A specialty in infant mental health requires knowledge…

AIMS baby movement scale application in high-risk infants early intervention analysis.

PubMed

Wang, Y; Shi, J-P; Li, Y-H; Yang, W-H; Tian, Y-J; Gao, J; Li, S-J

2016-05-01

We investigated the application of Alberta Infant Motor Scale (AIMS) in screening motor development delay in the follow-up of high-risk infants who were discharged from NICU, to explain the state of infants' motor development and propose early individualized intervention. The study design was a randomized, single-blind trial by selecting patients between April 2015 and November 2015 in our hospital, children nerve recovery branch clinics and 77 cases of high-risk infants. We randomly divided the patients into observation group (39 cases) and control group (38 cases). To evaluate the application with AIMS, observation group was based on evaluation results for the first time to give rehabilitation training plan making, early intervention, control group according to the growth and development milestone in order to guide parents to take family training interval of 3 months. While comparing the two groups of high-risk infants before the intervention, the months of age, gender, risk factors, it was found that the AIMS scores, each position AIMS scores did not show a significant difference in percentile (p>0.05). There was also no significant difference between two groups in the seat and stand AIMS scores before and after intervention (p>0.05). However, the comparison of two groups of high-risk infants after intervention in comparison showed that the observation group supine AIMS scores and AIMS scores were significantly higher than the control group (p<0.05). Prone position AIMS scores observation group was also significantly higher than that of the control group (p<0.01). The corresponding percentile for two groups after the intervention of AIMS scores was less than 10% of cases, which was significantly lower in the observation group (p<0.01). AIMS can predict the development delay in high-risk infants, for improving the early hypernymic diagnosis and intervention.

Infant feeding bottle design, growth and behaviour: results from a randomised trial

PubMed Central

2012-01-01

Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male) healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31), one-way air valve: Philips Avent) versus Bottle B (n = 32), internal venting system: Dr Browns). 74 breast-fed reference infants were recruited, with randomisation (n = 24) to bottle A (n = 11) or B (n = 13) if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i) milk intake (ii) infant behaviour measured at 2 weeks (validated 3-day diary); (iii) risk of infection; (iv) continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2) SDS versus bottle B 0.51 (0.39), mean difference 0.23 (95% CI -0.31 to 0.77). Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p < 0.05) than those using bottle B. There was no significant difference in any other outcome measure. Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in

A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India.

PubMed

Ella, Raches; Bobba, Radhika; Muralidhar, Sanjay; Babji, Sudhir; Vadrevu, Krishna Mohan; Bhan, Maharaj Kishan

2018-03-15

The World Health Organization recommends that rotavirus vaccines should be included in all national immunization programs. Some currently licensed oral rotavirus vaccines contain a buffering agent (either as part of a ready-to-use liquid formulation or added during reconstitution) to reduce possible degradation of the vaccine virus in the infant gut, which poses several programmatic challenges (the large dose volume or the reconstitution requirement) during vaccine administration. Because ROTAVAC®, a WHO prequalified vaccine, was derived from the 116E neonatal strain, we evaluated the immunogenicity and safety of ROTAVAC® without buffer and ROTAVAC® with buffer in a phase 4, multicentre, single-blind, randomized clinical trial in healthy infants in India. 900 infants, approximately 6, 10 and 14 weeks of age, were assigned to 3 groups to receive ROTAVAC® (0.5 mL dose) orally: (i) 2.5 mL of citrate-bicarbonate buffer 5 minutes prior to administration of ROTAVAC® (Group I), (ii) ROTAVAC®, alone, without any buffer (Group II), or (iii) ROTAVAC®, mixed with buffer immediately before administration (Group III). Non-inferiority was compared among the groups for differences in serological responses (detected by serum anti-rotavirus IgA) and safety. Geometric mean titers post vaccination at day 84 (28 days after dose 3) were 19.6 (95%CI: 17.0, 22.7), 20.7 (95%CI: 17.9, 24) and 19.2 (95%CI: 16.8, 22.1) for groups I, II and III respectively. Further, seroconversion rates and distribution of adverse events were similar among groups. Administration of ROTAVAC® at a 0.5 mL dose volume without buffering agent was shown to be well tolerated and immunogenic. Given the homologous nature of the strain, it is plausible that ROTAVAC® replicates well and confers immunity even without buffer administration.

Sustained versus intermittent lung inflation for resuscitation of preterm infants: a randomized controlled trial.

PubMed

El-Chimi, Mohamed S; Awad, Hisham A; El-Gammasy, Tarek M; El-Farghali, Ola G; Sallam, Mohamed T; Shinkar, Dina M

2017-06-01

To evaluate efficacy and safety of delivery room (DR) sustained lung inflation (SLI) in resuscitation of preterm neonates. Randomized Controlled Trial including 112 preterm infants randomized to either SLI (n = 57) using T-piece resuscitator [maximum three inflations with maximum pressure of 30 cmH 2 O for 15 s followed by continuous positive airway pressure (CPAP) of 5-7 cmH 2 O] or conventional bag/mask inflation (CBMI) (n = 55) using traditional self-inflating bag (maximum pressure of 40 cmH 2 O at a rate of 40-60 per min). Failure was defined as the need for DR or first 72 h intubation. Cord and 2-h post-resuscitation blood samples were collected to measure interleukin (IL)-1β and tumor necrosis factor-α levels before and after intervention. SLI was associated with significantly higher success rate compared to CBMI [75.4 versus 54.5%; p = 0.017], lower need for DR intubation [5.3% versus 23.6%; (X 2  =   7.7; p = 0.005)], higher 5-min-Apgar score (median 8 versus 7; p = 0.018), shorter duration on nasal-CPAP (p = 0.017), and non-significantly different air leak (7% versus 11%; p = 0.3) and bronchopulmonary dysplasia rates among survivors (2% versus 11%; p = 0.09). Post-resuscitation IL-1β plasma levels increased significantly in CBMI (p = 0.009) and not in SLI group. Delivery room SLI is more effective than intermittent bag and mask inflation for improving short-term respiratory outcome in preterm infants, without significant adverse effects.

An Overview of Randomization and Minimization Programs for Randomized Clinical Trials

PubMed Central

Saghaei, Mahmoud

2011-01-01

Randomization is an essential component of sound clinical trials, which prevents selection biases and helps in blinding the allocations. Randomization is a process by which subsequent subjects are enrolled into trial groups only by chance, which essentially eliminates selection biases. A serious consequence of randomization is severe imbalance among the treatment groups with respect to some prognostic factors, which invalidate the trial results or necessitate complex and usually unreliable secondary analysis to eradicate the source of imbalances. Minimization on the other hand tends to allocate in such a way as to minimize the differences among groups, with respect to prognostic factors. Pure minimization is therefore completely deterministic, that is, one can predict the allocation of the next subject by knowing the factor levels of a previously enrolled subject and having the properties of the next subject. To eliminate the predictability of randomization, it is necessary to include some elements of randomness in the minimization algorithms. In this article brief descriptions of randomization and minimization are presented followed by introducing selected randomization and minimization programs. PMID:22606659

Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial

PubMed Central

Kelty-Stephen, Damian; Qureshi Ahmad, Mona; Mao, Wenyang; Cakert, Kelly; Osborne, John; Paydarfar, David

2015-01-01

OBJECTIVE: To evaluate the effect of stochastic resonance (SR) stimulation on preterm infant oxygen desaturation, bradycardia, and apnea events. We hypothesized that SR stimulation will reduce these events. METHODS: This was a randomized crossover study conducted from April 2012 to July 2014. Eligible preterm infants were not receiving ventilation support and had at least 1 clinically documented apnea, bradycardia, and/or oxygen desaturation event. The 3 outcome variables were as follows: oxygen desaturation, bradycardia, and apnea events. Infants received up to two 3- or 4-hour intervention periods of 30-minute alternating intervals of SR stimulation and no SR stimulation. The first intervention period was randomly assigned to begin with SR stimulation either on or off, whereas the next intervention period automatically began with the opposite on/off state. We compared the SR stimulation “on” periods with the SR stimulation “off” periods with each infant serving as his or her own control. RESULTS: The sample consisted of 36 infants with a mean (±SD) gestational age of 30.5 ± 3 weeks and a birth weight of 1409 ± 450 g. SR stimulation decreased the number of apneic events by 50%. SR stimulation ameliorated every aspect of clinically significant oxygen desaturation events, with a 20% to 35% decrease in the number, duration, and intensity of oxygen desaturation events when SR stimulation was on. Also, SR stimulation produced a nearly 20% reduction in the intensity of bradycardia events. CONCLUSIONS: SR stimulation may be a noninvasive and nonpharmacologic treatment option for apnea, oxygen desaturation, and some aspects of bradycardia in premature infants. PMID:26598451

Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial.

PubMed

Smith, Vincent C; Kelty-Stephen, Damian; Qureshi Ahmad, Mona; Mao, Wenyang; Cakert, Kelly; Osborne, John; Paydarfar, David

2015-12-01

To evaluate the effect of stochastic resonance (SR) stimulation on preterm infant oxygen desaturation, bradycardia, and apnea events. We hypothesized that SR stimulation will reduce these events. This was a randomized crossover study conducted from April 2012 to July 2014. Eligible preterm infants were not receiving ventilation support and had at least 1 clinically documented apnea, bradycardia, and/or oxygen desaturation event. The 3 outcome variables were as follows: oxygen desaturation, bradycardia, and apnea events. Infants received up to two 3- or 4-hour intervention periods of 30-minute alternating intervals of SR stimulation and no SR stimulation. The first intervention period was randomly assigned to begin with SR stimulation either on or off, whereas the next intervention period automatically began with the opposite on/off state. We compared the SR stimulation "on" periods with the SR stimulation "off" periods with each infant serving as his or her own control. The sample consisted of 36 infants with a mean (±SD) gestational age of 30.5 ± 3 weeks and a birth weight of 1409 ± 450 g. SR stimulation decreased the number of apneic events by 50%. SR stimulation ameliorated every aspect of clinically significant oxygen desaturation events, with a 20% to 35% decrease in the number, duration, and intensity of oxygen desaturation events when SR stimulation was on. Also, SR stimulation produced a nearly 20% reduction in the intensity of bradycardia events. SR stimulation may be a noninvasive and nonpharmacologic treatment option for apnea, oxygen desaturation, and some aspects of bradycardia in premature infants. Copyright © 2015 by the American Academy of Pediatrics.

Cot-nursing versus incubator care for preterm infants.

PubMed

Gray, Peter H; Flenady, Vicki

2011-08-10

Preterm infants are usually nursed in incubators, but cot-nursing may provide an alternative. While there may be benefits of nursing preterm infants in open cots, there may be potential risks such as nosocomial infection caused by more handling due to easier access. To assess effects of cot-nursing versus incubator care on temperature control and weight gain in preterm infants. The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of electronic databases including the Cochrane Central Register of Controlled Trials (The Cochrane Library), Oxford Database of Perinatal Trials, MEDLINE, CINAHL, and EMBASE, as well as previous reviews including cross references through November 2009. All trials using random or quasi-random patient allocation in which infants receiving care in standard newborn cots were compared to infants managed in a conventional air heated incubator. The authors independently assessed trial quality and extracted data for the primary outcomes of temperature control and weight gain. Meta-analysis was conducted using a fixed-effect model. Eleven potential studies were identified of which five, involving 247 infants, were included in this review. When compared to incubator care, cot-nursing resulted in no significant difference in mean body temperature (MD 0.02 degrees C; 95% CI -0.02 to 0.07, four trials), though the one trial that reported on episodes of hyperthermia found this to be statistically more common in the cot-nursing group (RR 1.48; 95% CI 1.04 to 2.09). There were no statistically significant differences in weight gain. In the cot-nursing group, fewer infants were breast fed on discharge (typical RR 0.74; 95% CI 0.48 to 1.14, three trials, 150 infants) and fewer infants died prior to hospital discharge (typical RR 0.59, 95% CI 0.28 to 1.25, four trials, 235 infants) but these results failed to reach statistical significance. The comparison of cot-nursing using a heated water-filled mattress

Near-infrared spectroscopy as a predictor of clinical deterioration: a case report of two infants with duct-dependent congenital heart disease.

PubMed

Mebius, Mirthe J; du Marchie Sarvaas, Gideon J; Wolthuis, Diana W; Bartelds, Beatrijs; Kneyber, Martin C J; Bos, Arend F; Kooi, Elisabeth M W

2017-03-16

Some infants with congenital heart disease are at risk of in-hospital cardiac arrest. To better foresee cardiac arrest in infants with congenital heart disease, it might be useful to continuously assess end-organ perfusion. Near-infrared spectroscopy is a non-invasive method to continuously assess multisite regional tissue oxygen saturation. We report on two infants with duct-dependent congenital heart disease who demonstrated a gradual change in cerebral and/or renal tissue oxygen saturation before cardiopulmonary resuscitation was required. In both cases, other clinical parameters such as heart rate, arterial oxygen saturation and blood pressure did not indicate that deterioration was imminent. These two cases demonstrate that near-infrared spectroscopy might contribute to detecting a deteriorating clinical condition and might therefore be helpful in averting cardiopulmonary collapse and need for resuscitation in infants with congenital heart disease.

Clinical and molecular characterisation of hyperinsulinaemic hypoglycaemia in infants born small-for-gestational age.

PubMed

Arya, Ved Bhushan; Flanagan, Sarah E; Kumaran, Anitha; Shield, Julian P; Ellard, Sian; Hussain, Khalid; Kapoor, Ritika R

2013-07-01

To characterise the phenotype and genotype of neonates born small-for-gestational age (SGA; birth weight <10th centile) who developed hyperinsulinaemic hypoglycaemia (HH). Clinical information was prospectively collected on 27 SGA neonates with HH, followed by sequencing of KCNJ11 and ABCC8. There was no correlation between the maximum glucose requirement and serum insulin levels. Serum insulin level was undetectable in five infants (19%) during hypoglycaemia. Six infants (22%) required diazoxide treatment >6 months. Normoglycaemia on diazoxide <5 mg/kg/day was a safe predictor of resolved HH. Sequencing of KCNJ11/ABCC8 did not identify any mutations. Serum insulin levels during hypoglycaemia taken in isolation can miss the diagnosis of HH. SGA infants may continue to have hypofattyacidaemic hypoketotic HH beyond the first few weeks of life. Recognition and treatment of this group of patients are important and may have important implications for neurodevelopmental outcome of these patients.

Clinical and molecular characterisation of hyperinsulinaemic hypoglycaemia in infants born small-for-gestational age

PubMed Central

Arya, Ved Bhushan; Flanagan, Sarah E; Kumaran, Anitha; Shield, Julian P; Ellard, Sian; Hussain, Khalid; Kapoor, Ritika R

2013-01-01

Objective To characterise the phenotype and genotype of neonates born small-for-gestational age (SGA; birth weight <10th centile) who developed hyperinsulinaemic hypoglycaemia (HH). Methods Clinical information was prospectively collected on 27 SGA neonates with HH, followed by sequencing of KCNJ11 and ABCC8. Results There was no correlation between the maximum glucose requirement and serum insulin levels. Serum insulin level was undetectable in five infants (19%) during hypoglycaemia. Six infants (22%) required diazoxide treatment >6 months. Normoglycaemia on diazoxide <5 mg/kg/day was a safe predictor of resolved HH. Sequencing of KCNJ11/ABCC8 did not identify any mutations. Conclusions Serum insulin levels during hypoglycaemia taken in isolation can miss the diagnosis of HH. SGA infants may continue to have hypofattyacidaemic hypoketotic HH beyond the first few weeks of life. Recognition and treatment of this group of patients are important and may have important implications for neurodevelopmental outcome of these patients. PMID:23362136

The effect of maternal presence on premature infant response to recorded music.

PubMed

Dearn, Trish; Shoemark, Helen

2014-01-01

To determine the effect of maternal presence on the physiological and behavioral status of the preterm infant when exposed to recorded music versus ambient sound. Repeated-measures randomized controlled trial. Special care nursery (SCN) in a tertiary perinatal center. Clinically stable preterm infants (22) born at > 28 weeks gestation and enrolled at > 32 weeks gestation and their mothers. Infants were exposed to lullaby music (6 minutes of ambient sound alternating with 2x 6 minutes recorded lullaby music) at a volume within the recommended sound level for the SCN. The mothers in the experimental group were present for the first 12 minutes (baseline and first music period) whereas the mothers in the control group were absent overall. There was no discernible infant response to music and therefore no significant impact of maternal presence on infant's response to music over time. However during the mothers' presence (first 12 minutes), the infants exhibited significantly higher oxygen saturation than during their absence p = .024) and less time spent in quiet sleep after their departure, though this was not significant. Infants may have been unable to detect the music against the ambient soundscape. Regardless of exposure to music, the infants' physiological and behavioral regulation were affected by the presence and departure of the mothers. © 2014 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Effect of combined maternal and infant food-allergen avoidance on development of atopy in early infancy: a randomized study.

PubMed

Zeiger, R S; Heller, S; Mellon, M H; Forsythe, A B; O'Connor, R D; Hamburger, R N; Schatz, M

1989-07-01

The effect of maternal and infant avoidance of allergenic foods on food allergy was examined in a prenatally randomized, controlled trial of infants of atopic parents. The diet of the prophylactic-treated group (N = 103) included (1) maternal avoidance of cow's milk, egg, and peanut during the third trimester of pregnancy and lactation and (2) infant use of casein hydrolysate (Nutramigen) for supplementation or weaning, and avoidance of solid foods for 6 months; cow's milk, corn, soy, citrus, and wheat, for 12 months; and egg, peanut, and fish, for 24 months. In the control group (N = 185), mothers had unrestricted diets, and infants followed American Academy of Pediatrics feeding guidelines. The cumulative prevalence of atopy was lower at 12 months in the prophylactic-treated (16.2%) compared to the control (27.1%) group (p = 0.039), resulting from reduced food-associated atopic dermatitis, urticaria and/or gastrointestinal disease by 12 months (5.1% versus 16.4%; p = 0.007), and any positive food skin test by 24 months (16.5% versus 29.4%; p = 0.019), caused primarily by fewer positive milk skin tests (1% versus 12.4%; p = 0.001). The prevalences of allergic rhinitis, asthma, and inhalant skin tests were unaffected. Serum IgE levels in the prophylactic-treated group were marginally lower only at 4 months. Thus, reduced exposure of infants to allergenic foods appeared to reduce food sensitization and allergy primarily during the first year of life.

The Contrast Sensitivity of the Newborn Human Infant

PubMed Central

Brown, Angela M.; Lindsey, Delwin T.; Cammenga, Joanna G.; Giannone, Peter J.; Stenger, Michael R.

2015-01-01

Purpose. To measure the binocular contrast sensitivity (CS) of newborn infants using a fixation-and-following card procedure. Methods. The CS of 119 healthy newborn infants was measured using stimuli printed on cards under the descending method of limits (93 infants) and randomized/masked designs (26 infants). One experienced and one novice adult observer tested the infants using vertical square-wave gratings (0.06 and 0.10 cyc/deg; 20/10,000 and 20/6000 nominal Snellen equivalent); the experienced observer also tested using horizontal gratings (0.10 cyc/deg) and using the Method of Constant Stimuli while being kept unaware of the stimulus values. Results. The CS of the newborn infant was 2.0 (contrast threshold = 0.497; 95% confidence interval: 0.475–0.524) for vertically oriented gratings and 1.74 (threshold = 0.575; 95% confidence interval: 0.523–0.633) for horizontally oriented gratings (P < 0.0006). The standard deviation of infant CS was comparable to that obtained by others on adults using the Pelli-Robson chart. The two observers showed similar practice effects. Randomization of stimulus order and masking of the adult observer had no effect on CS. Conclusions. The CS of individual newborn human infants can be measured using a fixation-and-following card procedure. PMID:25564453

The association between maternal periodontitis and low birth weight infants among Malay women.

PubMed

Saddki, Norkhafizah; Bachok, Norsa'adah; Hussain, Nik Hazlina Nik; Zainudin, Siti Lailatul Akmar; Sosroseno, Wihaskoro

2008-08-01

Maternal periodontitis has been suggested as one of the risk factors for low birth weight (LBW) infants. The objective of this study was to determine the association between maternal periodontitis and LBW infants among Malay women. Screening periodontal examinations were carried out on all eligible Malay pregnant women in the second trimester of pregnancy attending two randomly selected community maternal and child health clinics in Kota Bharu, Kelantan. Patients with four or more sites with pocket depth 4 mm or higher, and clinical attachment loss 3 mm or higher at the same site with presence of bleeding on probing were diagnosed as having periodontitis in this study. Using this definition, systematic random sampling was utilized for selection of 250 subjects for each exposed and non-exposed group. Of 500 subjects enrolled in the study, 28 (5.6%) were either dropped or lost to follow-up. Of the remaining 472 subjects, 232 with periodontitis were in the exposed group and 240 with healthy periodontium were in the nonexposed group. The incidence of LBW was 14.2% (95% CI: 9.70-18.75) in women with periodontitis, and 3.3% (95% CI: 1.05-5.62) in women without periodontitis. The relative risk of having LBW infants was 4.27 times higher for women with periodontitis compared with those without periodontitis (95% CI: 2.01-9.04). After adjustment for potential confounders using multiple logistic regression analysis, significant association was found between maternal periodontitis and LBW (OR = 3.84; 95% CI: 1.34-11.05). The results of this study provide additional evidence that pregnant women with periodontitis are at a significantly higher risk of delivering LBW infants.

Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.

PubMed

Trevisanuto, Daniele; Putoto, Giovanni; Pizzol, Damiano; Serena, Tiziana; Manenti, Fabio; Varano, Silvia; Urso, Eleonora; Massavon, William; Tsegaye, Ademe; Wingi, Oliver; Onapa, Emanuel; Segafredo, Giulia; Cavallin, Francesco

2016-05-26

Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high-resource countries, but is of fundamental importance in low-resource settings where supportive care is limited. Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect on temperature control during KMC remains to be established. In the hospitals participating in the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the heads of the babies often remain uncovered due to local habits or to the unavailability of a cap. The aim of the present study will be to assess the effectiveness and safety of using a woolen cap in maintaining normothermia in low-birth-weight infants (LBWI) during KMC. This is a multicenter (three hospitals), multicountry (three countries), prospective, unblinded, randomized controlled trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight below 2500 g and who are candidates for KMC, based on the clinical decision of the attending physician, will be assigned to the KMC with a woolen cap group or to the KMC without a woolen cap group in a 1:1 ratio according to a computer-generated, randomized sequence. The duration of the study will be until the patient's discharge, with a maximum treatment duration of 7 days. The primary outcome measure will be whether the infants' temperatures remain within the normal range (36.5-37.5 °C) in the course of KMC during the intervention. In all participants, axillary temperature will be measured with a digital thermometer four times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before

Improvement in Growth After 1 Year of Growth Hormone Therapy in Well-Nourished Infants with Growth Retardation Secondary to Chronic Renal Failure: Results of a Multicenter, Controlled, Randomized, Open Clinical Trial

PubMed Central

Moreno, M. Llanos; Neto, Arlete; Ariceta, Gema; Vara, Julia; Alonso, Angel; Bueno, Alberto; Afonso, Alberto Caldas; Correia, António Jorge; Muley, Rafael; Barrios, Vicente; Gómez, Carlos; Argente, Jesús

2010-01-01

Background and objectives: Our aim was to evaluate the growth-promoting effect of growth hormone (GH) treatment in infants with chronic renal failure (CRF) and persistent growth retardation despite adequate nutritional and metabolic management. Design, setting, participants, & measurements: The study design included randomized, parallel groups in an open, multicenter trial comparing GH (0.33 mg/kg per wk) with nontreatment with GH during 12 months. Sixteen infants who had growth retardation, were aged 12 ± 3 months, had CRF (GFR ≤60 ml/min per 1.73 m2), and had adequate nutritional intake and good metabolic control were recruited from eight pediatric nephrology departments from Spain and Portugal. Main outcome measures were body length, body weight, bone age, biochemical and hormonal analyses, renal function, bone mass, and adverse effects. Results: Length gain in infants who were treated with GH was statistically greater (P < 0.05) than that of nontreated children (14.5 versus 9.5 cm/yr; SD score 1.43 versus −0.11). The GH-induced stimulation of growth was associated with no undesirable effects on bone maturation, renal failure progression, or metabolic control. In addition, GH treatment improved forearm bone mass and increased serum concentrations of total and free IGF-I and IGF-binding protein 3 (IGFBP-3), whereas IGF-II, IGFBP-1, IGFBP-2, GH-binding protein, ghrelin, and leptin were not modified. Conclusions: Infants with CRF and growth retardation despite good metabolic and nutritional control benefit from GH treatment without adverse effects during 12 months of therapy. PMID:20522533

Diagnoses and Presenting Symptoms in an Infant Psychiatry Clinic: Comparison of Two Diagnostic Systems.

ERIC Educational Resources Information Center

Frankel, Karen A.; Boyum, Lisa A.; Harmon, Robert J.

2004-01-01

Objective: To present data from a general infant psychiatry clinic, including range and frequency of presenting symptoms, relationship between symptoms and diagnoses, and comparison of two diagnostic systems, DSM-IV and Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood (DC: 0-3). Method: A…

Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants.

PubMed

Perkin, Michael R; Logan, Kirsty; Tseng, Anna; Raji, Bunmi; Ayis, Salma; Peacock, Janet; Brough, Helen; Marrs, Tom; Radulovic, Suzana; Craven, Joanna; Flohr, Carsten; Lack, Gideon

2016-05-05

The age at which allergenic foods should be introduced into the diet of breast-fed infants is uncertain. We evaluated whether the early introduction of allergenic foods in the diet of breast-fed infants would protect against the development of food allergy. We recruited, from the general population, 1303 exclusively breast-fed infants who were 3 months of age and randomly assigned them to the early introduction of six allergenic foods (peanut, cooked egg, cow's milk, sesame, whitefish, and wheat; early-introduction group) or to the current practice recommended in the United Kingdom of exclusive breast-feeding to approximately 6 months of age (standard-introduction group). The primary outcome was food allergy to one or more of the six foods between 1 year and 3 years of age. In the intention-to-treat analysis, food allergy to one or more of the six intervention foods developed in 7.1% of the participants in the standard-introduction group (42 of 595 participants) and in 5.6% of those in the early-introduction group (32 of 567) (P=0.32). In the per-protocol analysis, the prevalence of any food allergy was significantly lower in the early-introduction group than in the standard-introduction group (2.4% vs. 7.3%, P=0.01), as was the prevalence of peanut allergy (0% vs. 2.5%, P=0.003) and egg allergy (1.4% vs. 5.5%, P=0.009); there were no significant effects with respect to milk, sesame, fish, or wheat. The consumption of 2 g per week of peanut or egg-white protein was associated with a significantly lower prevalence of these respective allergies than was less consumption. The early introduction of all six foods was not easily achieved but was safe. The trial did not show the efficacy of early introduction of allergenic foods in an intention-to-treat analysis. Further analysis raised the question of whether the prevention of food allergy by means of early introduction of multiple allergenic foods was dose-dependent. (Funded by the Food Standards Agency and others; EAT

Randomized controlled trial to prevent infant overweight in a high-risk population

USDA-ARS?s Scientific Manuscript database

Infants are at risk of overweight. Infant overweight predisposes child, adolescent, and adult to obesity. We hypothesized that parent education, initiated prenatally and provided in the home, would reduce the incidence of infant overweight at age 12 months. Pregnant obese Latina women were recruited...

Northern infant syndrome: a deficiency state?

PubMed

Godel, J C; Hart, A G

1984-08-01

A syndrome is described that affected 16 Indian and Inuit infants roughly 3 months old, most of whom were born in settlements in the Canadian Arctic. The infants presented with a clinical picture that included hepatitis, hemolytic anemia, rickets and respiratory distress, a combination that resembled a syndrome first described in malnourished infants at the turn of the century by von Jaksch and Luzet. The clinical course was self-limited, and all the infants survived without sequelae. The cause of the syndrome was not determined; no infectious agents were discovered. However, low levels of vitamins A, C, D and E were found in a few infants in whom assays were done. The implications of these findings and their relation to the possible cause of this "northern infant syndrome" are discussed.

[Experimental and clinical evaluation of latamoxef in newborn and premature infants].

PubMed

Motohiro, T; Tanaka, K; Koga, T; Shimada, Y; Tomita, N; Sakata, Y; Fujimoto, T; Nishiyama, T; Ishimoto, K; Tominaga, K

1983-09-01

Latamoxef (LMOX) was administered as a one-shot intravenous injection of 10 mg/kg or 20 mg/kg to 28 newborn and immature infants of 1 to 28 days of age. For 6 hours following the administration, the concentrations of the drug in the plasma and in the urine were monitored and the urinary recovery rate was determined. In addition, 17 patients, consisting of newborns, immature infants and suckling infants, aged 0 days to 2 months and diagnosed as having various bacterial infections, were also treated with LMOX; the mean daily dosage was 103 mg/kg, administered in 2 to 6 divided doses as one-shot intravenous injections for an average duration of 11 days. These patients were subjected to the analysis for the clinical efficacy and bacteriological efficacy of the therapy. Furthermore, with the inclusion of 35 drop-out cases, a total of 52 patients was investigated for the occurrence of side effects by the LMOX therapy. The findings of these studies are summarized below. The patients were divided into 5 groups on the basis of age: 3 days old or less, 4--7 days, 8--14 days, 15--21 days and 22--28 days. Only in the 8--14 day-old group administered LMOX at 20 mg/kg, the maximum mean plasma concentration of the drug occurred at the time of 15 minutes postadministration, although some individuals showed peaks at 5 minutes. In all of the other age groups, for both the 10 and 20 mg/kg dosages, the maximum plasma concentration of LMOX occurred 5 minutes postinjection. In each of the age groups, a dose response was seen between the 2 dosage levels. However, a comparison of each group and control infants in terms of the LMOX plasma concentration at 30 minutes after injection revealed that the concentrations in the patients in this study were low. In terms of the half-life of the drug at the 2 dosage levels, both the mean and individual values in each of the age groups were longer than the half-lives in control infants. This tendency was especially marked in the case of infants 7

Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study.

PubMed

Bingler, Michael; Erickson, Lori A; Reid, Kimberly J; Lee, Brian; O'Brien, James; Apperson, Johnathan; Goggin, Kathy; Shirali, Girish

2018-05-01

Interstage outcomes for infants with single ventricle remain suboptimal. We have previously described a tablet PC-based platform Cardiac High Acuity Monitoring Program (CHAMP) for remote monitoring which provides immediate access to data, videos, and instant alerts to our single ventricle care team. This study compares traditional three-ring binder monitoring (Binder) to CHAMP using a randomized crossover design to evaluate mortality, resource utilization, and caregiver experience. At discharge, all single ventricle infants were monitored using Binder and randomized to receive CHAMP at either one or two months postdischarge. One month after randomization, caregivers could choose either Binder or CHAMP for the remainder of the interstage period. Caregivers experience was recorded using surveys. Enrollment included 31 single ventricle infants from May 2014 to June 2015. There was no interstage mortality over 4,911 total interstage days (median: 144/patient). Of 73 readmissions, 45 were unplanned. Of the initial 23 unplanned readmissions, 13 were found to have been based on data obtained exclusively through CHAMP (as instant alerts or based on data review) rather than caregiver concerns. Due to concerns regarding patient safety, additional enrollment was stopped. The CHAMP use was associated with significantly fewer unplanned intensive care unit days/100 interstage days, shorter delays in care, lower resource utilization at readmissions, and lower incidence of interstage growth failure and was preferred by a majority of caregivers. These findings suggest that CHAMP may offer benefits over Binder (improved interstage outcomes, delays in care, and caregiver experience). These findings should be tested across multiple centers in larger populations.

Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial

PubMed Central

2012-01-01

Background Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season. Methods Healthy infants aged 5–10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI. Results Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75

Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial.

PubMed

Steele, Andrew Duncan; Neuzil, Kathleen M; Cunliffe, Nigel A; Madhi, Shabir A; Bos, Pieter; Ngwira, Bagrey; Witte, Desiree; Todd, Stacy; Louw, Cheryl; Kirsten, Mari; Aspinall, Sanet; Van Doorn, Leen Jan; Bouckenooghe, Alain; Suryakiran, Pemmaraju V; Han, Htay Htay

2012-09-13

Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season. Healthy infants aged 5-10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI. Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87

Perinatal Consumption of Thiamine-Fortified Fish Sauce in Rural Cambodia: A Randomized Clinical Trial.

PubMed

Whitfield, Kyly C; Karakochuk, Crystal D; Kroeun, Hou; Hampel, Daniela; Sokhoing, Ly; Chan, Benny B; Borath, Mam; Sophonneary, Prak; McLean, Judy; Talukder, Aminuzzaman; Lynd, Larry D; Li-Chan, Eunice C Y; Kitts, David D; Allen, Lindsay H; Green, Timothy J

2016-10-03

Infantile beriberi, a potentially fatal disease caused by thiamine deficiency, remains a public health concern in Cambodia and regions where thiamine-poor white rice is a staple food. Low maternal thiamine intake reduces breast milk thiamine concentrations, placing breastfed infants at risk of beriberi. To determine if consumption of thiamine-fortified fish sauce yields higher erythrocyte thiamine diphosphate concentrations (eTDP) among lactating women and newborn infants and higher breast milk thiamine concentrations compared with a control sauce. In this double-blind randomized clinical trial, 90 pregnant women were recruited in the Prey Veng province, Cambodia. The study took place between October 2014 and April 2015. Women were randomized to 1 of 3 groups (n = 30) for ad libitum fish sauce consumption for 6 months: control (no thiamine), low-concentration (2 g/L), or high-concentration (8 g/L) fish sauce. Maternal eTDP was assessed at baseline (October 2014) and endline (April 2015). Secondary outcomes, breast milk thiamine concentration and infant eTDP, were measured at endline. Women's mean (SD) age and gestational stage were 26 (5) years and 23 (7) weeks, respectively. April 2015 eTDP was measured among 28 women (93%), 29 women (97%), and 23 women (77%) in the control, low-concentration, and high-concentration groups, respectively. In modified intent-to-treat analysis, mean baseline-adjusted endline eTDP was higher among women in the low-concentration (282nM; 95% CI, 235nM to 310nM) and high-concentration (254nM; 95% CI, 225nM to 284nM) groups compared with the control group (193nM; 95% CI, 164nM to 222M; P < .05); low-concentration and high-concentration groups did not differ (P = .19). Breast milk total thiamine concentrations were 14.4 μg/dL for the control group (95% CI, 12.3 μg/dL to 16.5 μg/dL) (to convert to nanomoles per liter, multiply by 29.6); 20.7 μg/dL for the low-concentration group (95% CI, 18.6 μg/dL to 22.7 μg/dL ); and 17

Bone mineral content (BMC) and serum vitamin D concentrations of infants fed partially hydrolyzed infant formulas

USDA-ARS?s Scientific Manuscript database

The purpose of the study was to compare the bone status of healthy, term infants fed partially hydrolyzed whey formulas during the first 3 mo of life. Between 0 and 8 d of age, 89 infants were randomized to Good Start Supreme (GSS) or an experimental whey-based formula (EF) to 84 d of age. BMC was a...

Concurrent validity and reliability of the Alberta Infant Motor Scale in premature infants.

PubMed

Almeida, Kênnea Martins; Dutra, Maria Virginia Peixoto; Mello, Rosane Reis de; Reis, Ana Beatriz Rodrigues; Martins, Priscila Silveira

2008-01-01

To verify the concurrent validity and interobserver reliability of the Alberta Infant Motor Scale (AIMS) in premature infants followed-up at the outpatient clinic of Instituto Fernandes Figueira, Fundação Oswaldo Cruz (IFF/Fiocruz), in Rio de Janeiro, Brazil. A total of 88 premature infants were enrolled at the follow-up clinic at IFF/Fiocruz, between February and December of 2006. For the concurrent validity study, 46 infants were assessed at either 6 (n = 26) or 12 (n = 20) months' corrected age using the AIMS and the second edition of the Bayley Scales of Infant Development, by two different observers, and applying Pearson's correlation coefficient to analyze the results. For the reliability study, 42 infants between 0 and 18 months were assessed using the Alberta Infant Motor Scale, by two different observers and the results analyzed using the intraclass correlation coefficient. The concurrent validity study found a high level of correlation between the two scales (r = 0.95) and one that was statistically significant (p < 0.01) for the entire population of infants, with higher values at 12 months (r = 0.89) than at 6 months (r = 0.74). The interobserver reliability study found satisfactory intraclass correlation coefficients at all ages tested, varying from 0.76 to 0.99. The AIMS is a valid and reliable instrument for the evaluation of motor development in high-risk infants within the Brazilian public health system.

Reducing hypothermia in preterm infants with polyethylene wrap.

PubMed

Rohana, Jaafar; Khairina, Wan; Boo, Nem Yun; Shareena, Ishak

2011-08-01

Occlusive plastic applied immediately after birth to reduce evaporative heat loss has been proven effective in preterm infants <28 weeks' gestation. However its effectiveness on preterm infants >28 weeks' gestation has not been shown. This study aimed to determine the effect of occlusive wrap at birth on the temperature at neonatal intensive care unit (NICU) admission among infants of greater than or equal to 24 weeks' and less than 34 weeks' gestation. Study infants were randomly assigned to "wrap" or "control" groups. Newborns in the wrap group were wrapped with polyethylene plastic sheets within the first min after birth. Infants randomized to the control group were dried immediately after birth with warmed towels under a warmer, according to the guidelines of Neonatal Resuscitation. Infants' axillary temperatures were measured on admission to the NICU, and after having been stabilized in incubators in the NICU. A total of 110 infants were recruited into the study. The mean admission temperature was significantly higher in the wrap group (35.8 vs 34.8°C, P < 0.01). Admission hypothermia (axillary temperature <36.5°C) was present in 38 (78%) and 58 (98%) infants in the wrap and control groups, respectively. Among infants of <28 weeks' gestation, the post-stabilization temperature was significantly higher in the wrap group. Wrapping premature infants with gestational age <34 weeks in polyethylene plastics immediately after birth is associated with lower incidence of hypothermia. © 2011 The Authors. Pediatrics International © 2011 Japan Pediatric Society.

The Special Supplemental Nutrition Program for Women, Infants, and Children Fresh Start randomized controlled trial: Baseline participant characteristics and reliability of measures

USDA-ARS?s Scientific Manuscript database

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Fresh Start (WFS) is a randomized controlled trial of nutrition education to promote farmers' market fruit and vegetable (F/V) purchases and consumption among women enrolled in WIC. Our objectives were to describe the ...

Comparison of growth and nutritional status in infants receiving goat milk-based formula and cow milk-based formula: a randomized, double-blind study.

PubMed

Xu, Meihong; Wang, Yibin; Dai, Zhiyong; Zhang, Yanchun; Li, Yong; Wang, Junbo

2015-01-01

To compare the growth and nutritional status of infants fed goat milk-based formula (GMF) and cow milk-based formula (CMF). The study was conducted in Beijing, China. It was a double-blind randomized controlled trial. A total of 79 infants aged 0-3 months old were recruited and randomized in GMF or CMF group. The infants were fed the allocated formula to 6 months. The weight, length, and head circumference were measured at the enrolment, 3 and 6 months. The start time and types of solid food were recorded. Blood elements, urinal, and fecal parameters were also tested. The average weight of infants in the GMF group (mean±SD) was 4.67±0.99 kg and in the CMF group 4.73±1.10 kg at enrolment, and 8.75±0.98 kg (GMF) and 8.92±0.88 kg (CMF) at 6 months. There were no differences in the adjusted intention-to-treat analyses of weight, length, head circumference, and BMI z-scores between the two formula-fed groups over the 6-month study. Similarly, there were no remarkable differences in the timing and types of solid food, blood elements, urinal, and feces parameters, between the GMF and CMF group. No group differences have been shown in bowel motion consistency, duration of crying, ease of settling, or frequency of adverse events. GMF-provided growth and nutritional outcomes did not differ from those provided by CMF.

Trends in US Hospital Stays for Listeriosis in Infants.

PubMed

Veesenmeyer, Angela F; Edmonson, M Bruce

2016-04-01

Although listeriosis is rare in infants, it is common for young infants with suspected serious bacterial infection to be treated empirically with agents selected, in part, for their activity against Listeria monocytogenes. Our objectives were to describe the recent epidemiology of hospital discharges for listeriosis among infants in the United States and to precisely estimate the incidence of listeriosis according to infant age and meningitis status. We generated national estimates for listeriosis discharges in each of the 6 years for which samples were available in the Kids' Inpatient Database during the period 1997-2012. We used random-effects models to pool descriptive information and population rates across study years. The cumulative number of US hospital discharges for listeriosis in infants was 344 (95% confidence interval [CI]: 290-397) over the 6 study years. The pooled annual incidence rate in infants (per 100,000 births) was 1.41 (95% CI: 1.01-1.80) after accounting for marked fluctuation in annual rates (range: 0.66-1.86; I2=79.3%). Discharges for listeriosis without meningitis were particularly rare after the first week of life. Our models predicted only 2.7 (95% CI: 1.1-4.2) and 1.8 (95% CI: 0.0-3.6) such discharges per year in infants admitted at ages 7 to 28 days and 29 to 364 days, respectively. From the perspective of providing coverage against listeriosis, the routine practice of including ampicillin in the empirical treatment of febrile infants should be reevaluated for those older than 1 week without clinical evidence of meningitis. Copyright © 2016 by the American Academy of Pediatrics.

Direct and Indirect Effects of Behavioral Parent Training on Infant Language Production

PubMed Central

Bagner, Daniel M.; Garcia, Dainelys; Hill, Ryan

2016-01-01

Given the strong association between early behavior problems and language impairment, we examined the effect of a brief home-based adaptation of Parent–child Interaction Therapy on infant language production. Sixty infants (55% male; mean age 13.47 ± 1.31 months) were recruited at a large urban primary care clinic and were included if their scores exceeded the 75th percentile on a brief screener of early behavior problems. Families were randomly assigned to receive the home-based parenting intervention or standard pediatric primary care. The observed number of infant total (i.e., token) and different (i.e., type) utterances spoken during an observation of an infant-led play and a parent-report measure of infant externalizing behavior problems were examined at pre- and post-intervention and at 3- and 6-month follow-ups. Infants receiving the intervention demonstrated a significantly higher number of observed different and total utterances at the 6-month follow-up compared to infants in standard care. Furthermore, there was an indirect effect of the intervention on infant language production, such that the intervention led to decreases in infant externalizing behavior problems from pre- to post-intervention, which, in turn, led to increases in infant different utterances at the 3- and 6-month follow-ups and total utterances at the 6-month follow-up. Results provide initial evidence for the effect of this brief and home-based intervention on infant language production, including the indirect effect of the intervention on infant language through improvements in infant behavior, highlighting the importance of targeting behavior problems in early intervention. PMID:26956651

Direct and Indirect Effects of Behavioral Parent Training on Infant Language Production.

PubMed

Bagner, Daniel M; Garcia, Dainelys; Hill, Ryan

2016-03-01

Given the strong association between early behavior problems and language impairment, we examined the effect of a brief home-based adaptation of Parent-child Interaction Therapy on infant language production. Sixty infants (55% male; mean age 13.47±1.31 months) were recruited at a large urban primary care clinic and were included if their scores exceeded the 75th percentile on a brief screener of early behavior problems. Families were randomly assigned to receive the home-based parenting intervention or standard pediatric primary care. The observed number of infant total (i.e., token) and different (i.e., type) utterances spoken during an observation of an infant-led play and a parent-report measure of infant externalizing behavior problems were examined at pre- and post-intervention and at 3- and 6-month follow-ups. Infants receiving the intervention demonstrated a significantly higher number of observed different and total utterances at the 6-month follow-up compared to infants in standard care. Furthermore, there was an indirect effect of the intervention on infant language production, such that the intervention led to decreases in infant externalizing behavior problems from pre- to post-intervention, which, in turn, led to increases in infant different utterances at the 3- and 6-month follow-ups and total utterances at the 6-month follow-up. Results provide initial evidence for the effect of this brief and home-based intervention on infant language production, including the indirect effect of the intervention on infant language through improvements in infant behavior, highlighting the importance of targeting behavior problems in early intervention. Copyright © 2015. Published by Elsevier Ltd.

Use of a pacifier and behavioural features in 2-4-month-old infants.

PubMed

Kelmanson, I A

1999-11-01

This study aimed to analyse a possible association between the use of a pacifier and particular behavioural features in 2-4-month-old infants as estimated by the means of the Early Infancy Temperament Questionnaire (EITQ). It comprised 192 randomly selected clinically healthy infants born in St Petersburg in 1997-1998. The mothers were asked to complete the questionnaires addressing infant, maternal and major demographic characteristics, and childcare practices, with particular emphasis on the use of a pacifier, as well as to fill in the EITQ. The EITQ scores nine different aspects of infant temperament: activity, rhythmicity, approach, adaptability, intensity, mood, persistence, distractibility and threshold. A total of 117 of 192 infants (60.9%) used pacifiers, and they appeared to have more rhythmic behaviour than non-users. This effect remained after adjustment was made for major potential confounding and/or modifying factors, including gender, parity, details from perinatal history and familial social background, feeding pattern, bed sharing and room sharing. With the exception of rhythmicity, no significant association was found between the use of a pacifier and any other particular feature of infant temperament. Use of a pacifier may be associated with higher rhythmicity in 2-4-month-old infants.

The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants.

PubMed

Kang, Jin Han; Lee, Hoan Jong; Kim, Kyung Hyo; Oh, Sung Hee; Cha, Sung Ho; Lee, Jin; Kim, Nam Hee; Eun, Byung Wook; Kim, Chang Hwi; Hong, Young Jin; Kim, Hyun Hee; Lee, Kyung Yil; Kim, Yae Jean; Cho, Eun Young; Kim, Hee Soo; Guitton, Fabrice; Ortiz, Esteban

2016-09-01

Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim™) compared with licensed DTaP-IPV and Hib (PRP~T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IPV and Hib vaccines (n = 206) or the pentavalent DTaP-IPV//Hib (n = 208) vaccine at 2, 4, 6 months of age. Antibodies to all components were measured before the first vaccination and one month after the third, and safety was assessed after each vaccination including recording of reactions by parents. We confirmed the non-inferiority of DTaP-IPV//Hib compared with DTaP-IPV and Hib vaccines; 100% of both groups achieved seroprotection against D, T, IPV and PRP~T, and 97.5%-99.0% demonstrated seroresponses to pertussis antigens. Antibody levels were similar in both groups, except for those to the Hib component, PRP~T. In separate and combined groups geometric mean concentrations of anti-PRP~T antibodies were 23.9 and 11.0 μg/mL, respectively, but 98.3% and 97.4% had titers ≥ 1 μg/mL, indicative of long-term protection. All vaccines were well tolerated, with no vaccine-related serious adverse event. Both groups had similar safety profiles, but the combined vaccine group had fewer injection site reactions. The immunological non-inferiority and similar safety profile of DTaP-IPV//Hib vaccine to separate DTaP-IPV and Hib vaccines, with the advantage of fewer injections and injection site reactions, supports the licensure and incorporation of DTaP-IPV//Hib into the Korean national vaccination schedule (Clinical trial registry, NCT01214889).

Clinical neuroimaging in the preterm infant: Diagnosis and prognosis.

PubMed

Hinojosa-Rodríguez, Manuel; Harmony, Thalía; Carrillo-Prado, Cristina; Van Horn, John Darrell; Irimia, Andrei; Torgerson, Carinna; Jacokes, Zachary

2017-01-01

Perinatal care advances emerging over the past twenty years have helped to diminish the mortality and severe neurological morbidity of extremely and very preterm neonates (e.g., cystic Periventricular Leukomalacia [c-PVL] and Germinal Matrix Hemorrhage - Intraventricular Hemorrhage [GMH-IVH grade 3-4/4]; 22 to < 32 weeks of gestational age, GA). However, motor and/or cognitive disabilities associated with mild-to-moderate white and gray matter injury are frequently present in this population (e.g., non-cystic Periventricular Leukomalacia [non-cystic PVL], neuronal-axonal injury and GMH-IVH grade 1-2/4). Brain research studies using magnetic resonance imaging (MRI) report that 50% to 80% of extremely and very preterm neonates have diffuse white matter abnormalities (WMA) which correspond to only the minimum grade of severity. Nevertheless, mild-to-moderate diffuse WMA has also been associated with significant affectations of motor and cognitive activities. Due to increased neonatal survival and the intrinsic characteristics of diffuse WMA, there is a growing need to study the brain of the premature infant using non-invasive neuroimaging techniques sensitive to microscopic and/or diffuse lesions. This emerging need has led the scientific community to try to bridge the gap between concepts or ideas from different methodologies and approaches; for instance, neuropathology, neuroimaging and clinical findings. This is evident from the combination of intense pre-clinical and clinicopathologic research along with neonatal neurology and quantitative neuroimaging research. In the following review, we explore literature relating the most frequently observed neuropathological patterns with the recent neuroimaging findings in preterm newborns and infants with perinatal brain injury. Specifically, we focus our discussions on the use of neuroimaging to aid diagnosis, measure morphometric brain damage, and track long-term neurodevelopmental outcomes.

The Power of an Infant's Smile: Maternal Physiological Responses to Infant Emotional Expressions.

PubMed

Mizugaki, Sanae; Maehara, Yukio; Okanoya, Kazuo; Myowa-Yamakoshi, Masako

2015-01-01

Infant emotional expressions, such as distress cries, evoke maternal physiological reactions. Most of which involve accelerated sympathetic nervous activity. Comparatively little is known about effects of positive infant expressions, such as happy smiles, on maternal physiological responses. This study investigated how physiological and psychological maternal states change in response to infants' emotional expressions. Thirty first-time mothers viewed films of their own 6- to 7-month-old infants' affective behavior. Each observed a video of a distress cry followed by a video showing one of two expressions (randomly assigned): a happy smiling face (smile condition) or a calm neutral face (neutral condition). Both before and after the session, participants completed a self-report inventory assessing their emotional states. The results of the self-report inventory revealed no effects of exposure to the infant videos. However, the mothers in the smile condition, but not in the neutral condition, showed deceleration of skin conductance. These findings demonstrate that the mothers who observed their infants smiling showed decreased sympathetic activity. We propose that an infant's positive emotional expression may affect the branch of the maternal stress-response system that modulates the homeostatic balance of the sympathetic and parasympathetic nervous systems.

Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age.

PubMed

Leuchter, Russia Ha-Vinh; Gui, Laura; Poncet, Antoine; Hagmann, Cornelia; Lodygensky, Gregory Anton; Martin, Ernst; Koller, Brigitte; Darqué, Alexandra; Bucher, Hans Ulrich; Hüppi, Petra Susan

2014-08-27

Premature infants are at risk of developing encephalopathy of prematurity, which is associated with long-term neurodevelopmental delay. Erythropoietin was shown to be neuroprotective in experimental and retrospective clinical studies. To determine if there is an association between early high-dose recombinant human erythropoietin treatment in preterm infants and biomarkers of encephalopathy of prematurity on magnetic resonance imaging (MRI) at term-equivalent age. A total of 495 infants were included in a randomized, double-blind, placebo-controlled study conducted in Switzerland between 2005 and 2012. In a nonrandomized subset of 165 infants (n=77 erythropoietin; n=88 placebo), brain abnormalities were evaluated on MRI acquired at term-equivalent age. Participants were randomly assigned to receive recombinant human erythropoietin (3000 IU/kg; n=256) or placebo (n=239) intravenously before 3 hours, at 12 to 18 hours, and at 36 to 42 hours after birth. The primary outcome of the trial, neurodevelopment at 24 months, has not yet been assessed. The secondary outcome, white matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method. The resulting white matter injury and gray matter injury scores were categorized as normal or abnormal according to thresholds established in the literature by correlation with neurodevelopmental outcome. At term-equivalent age, compared with untreated controls, fewer infants treated with recombinant human erythropoietin had abnormal scores for white matter injury (22% [17/77] vs 36% [32/88]; adjusted risk ratio [RR], 0.58; 95% CI, 0.35-0.96), white matter signal intensity (3% [2/77] vs 11% [10/88]; adjusted RR, 0.20; 95% CI, 0.05-0.90), periventricular white matter loss (18% [14/77] vs 33% [29/88]; adjusted RR, 0.53; 95% CI, 0.30-0.92), and gray matter injury (7% [5/77] vs 19% [17/88]; adjusted RR, 0.34; 95% CI, 0.13-0.89). In an analysis of secondary

A Randomized Clinical Trial to Determine Optimal Infertility Treatment in Older Couples: The Forty and Over Treatment Trial (FORT-T)

PubMed Central

Goldman, Marlene B.; Thornton, Kim L.; Ryley, David; Alper, Michael M.; Fung, June L.; Hornstein, Mark D.; Reindollar, Richard H.

2014-01-01

Objective To determine optimal infertility therapy in women at the end of their reproductive potential. Design Randomized clinical trial. Setting Academic medical centers and private infertility center in a state with mandated insurance coverage. Patients Couples with ≥ 6 months of unexplained infertility; female partner aged 38–42. Interventions Randomized to treatment with 2 cycles of clomiphene citrate (CC) and intrauterine insemination (IUI), follicle stimulating hormone (FSH)/IUI, or immediate IVF, followed by IVF if not pregnant. Main Outcome Measures Proportion with a clinically recognized pregnancy, number of treatment cycles, and time to conception after 2 treatment cycles and at the end of treatment. Results 154 couples were randomized to receive CC/IUI (N=51), FSH/IUI (N=52), or immediate IVF (N=51); 140 (90.9%) couples initiated treatment. Cumulative clinical pregnancy rates per couple after the first 2 cycles of CC/IUI, FSH/IUI, or immediate IVF were 21.6%, 17.3%, and 49.0%, respectively. After all treatment, 71.4% (110/154) of couples conceived a clinically recognized pregnancy and 46.1% delivered at least one live-born baby. 84.2% of all live born infants resulting from treatment were achieved from IVF. There were 36% fewer treatment cycles in the IVF arm compared to either COH/IUI arm and couples conceived a pregnancy leading to a live birth after fewer treatment cycles. Conclusions An RCT to compare treatment initiated with 2 cycles of COH/IUI to immediate IVF in older women with unexplained infertility demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group. PMID:24796764

Medical-Legal Strategies to Improve Infant Health Care: A Randomized Trial.

PubMed

Sege, Robert; Preer, Genevieve; Morton, Samantha J; Cabral, Howard; Morakinyo, Oluwatomisin; Lee, Vonne; Abreu, Catarina; De Vos, Edward; Kaplan-Sanoff, Margot

2015-07-01

Changes in health care delivery create opportunities to improve systems to better meet the needs of low-income families while achieving quality benchmarks. Families of healthy newborns receiving primary care at a single large urban safety-net hospital participated. Intervention families were randomly assigned a family specialist who provided support until the 6-month routine health care visit. The Developmental Understanding and Legal Collaboration for Everyone (DULCE) intervention is based on the Strengthening Families approach and incorporated components of the Healthy Steps and Medical-Legal Partnership models. Medical record reviews determined use of preventive and emergency care. Surveys conducted at baseline, postintervention (6 months), and follow-up (12 months) were used to determine hardship and attainment of concrete supports. Three hundred thirty families participated in the study. At baseline, 73% of families reported economic hardships. Intervention parents had an average of 14 contacts with the family specialist, and 5 hours of total contact time. Intervention infants were more likely to have completed their 6-month immunization schedule by age 7 months (77% vs 63%, P < .005) and by 8 months (88% vs 77%, P < .01). Intervention infants were more likely to have 5 or more routine preventive care visits by age 1 year (78% vs 67%, P < .01) and were less likely to have visited the emergency department by age 6 months (37% vs 49.7%, P < .03). The DULCE intervention accelerated access to concrete resources (P = .029). Assignment to the Project DULCE intervention led to improvements in preventive health care delivery and utilization and accelerated access to concrete supports among low-income families. Copyright © 2015 by the American Academy of Pediatrics.

The Infant Microbiome: Implications for Infant Health and Neurocognitive Development

PubMed Central

Yang, Irene; Corwin, Elizabeth J.; Brennan, Patricia A.; Jordan, Sheila; Murphy, Jordan R.; Dunlop, Anne

2015-01-01

Background Beginning at birth, the microbes in the gut perform essential duties related to the digestion and metabolism of food, the development and activation of the immune system, and the production of neurotransmitters that affect behavior and cognitive function. Objectives The objectives of this review are to: (a) provide a brief overview of the microbiome and the “microbiome-gut-brain axis”; (b) discuss factors known to affect the composition of the infant microbiome: mode of delivery, antibiotic exposure, and infant feeding patterns; and (c) present research priorities for nursing science, and clinical implications for infant health and neurocognitive development. Discussion The gut microbiome influences immunological, endocrine, and neural pathways and plays an important role in infant development. Several factors influence colonization of the infant gut microbiome. Different microbial colonization patterns are associated with vaginal versus surgical birth, exposure to antibiotics, and infant feeding patterns. Because of extensive physiological influence, infant microbial colonization patterns have the potential to impact physical and neurocognitive development and life course disease risk. Understanding these influences will inform newborn care and parental education. PMID:26657483

Parent-infant psychotherapy for improving parental and infant mental health.

PubMed

Barlow, Jane; Bennett, Cathy; Midgley, Nick; Larkin, Soili K; Wei, Yinghui

2015-01-08

95% confidence intervals (CI) for continuous data, and risk ratios (RR) for dichotomous data. We undertook meta-analysis using a random-effects model. We included eight studies comprising 846 randomised participants, of which four studies involved comparisons of PIP with control groups only. Four studies involved comparisons with another treatment group (i.e. another PIP, video-interaction guidance, psychoeducation, counselling or cognitive behavioural therapy (CBT)), two of these studies included a control group in addition to an alternative treatment group. Samples included women with postpartum depression, anxious or insecure attachment, maltreated, and prison populations. We assessed potential bias (random sequence generation, allocation concealment, incomplete outcome data, selective reporting, blinding of participants and personnel, blinding of outcome assessment, and other bias). Four studies were at low risk of bias in four or more domains. Four studies were at high risk of bias for allocation concealment, and no study blinded participants or personnel to the intervention. Five studies did not provide adequate information for assessment of risk of bias in at least one domain (rated as unclear).Six studies contributed data to the PIP versus control comparisons producing 19 meta-analyses of outcomes measured at post-intervention or follow-up, or both, for the primary outcomes of parental depression (both dichotomous and continuous data); measures of parent-child interaction (i.e. maternal sensitivity, child involvement and parent engagement; infant attachment category (secure, avoidant, disorganised, resistant); attachment change (insecure to secure, stable secure, secure to insecure, stable insecure); infant behaviour and secondary outcomes (e.g. infant cognitive development). The results favoured neither PIP nor control for incidence of parental depression (RR 0.74, 95% CI 0.52 to 1.04, 3 studies, 278 participants, low quality evidence) or parent