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Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.

ABSTRACT: This study was a comparison of growth and tolerance in premature infants fed either standard powdered human milk fortifier (HMF) or a newly formulated concentrated liquid that contained extensively hydrolyzed protein.This was an unblinded randomized controlled multicenter noninferiority study on preterm infants receiving human milk (HM) supplemented with 2 randomly assigned HMFs, either concentrated liquid HMF containing extensively hydrolyzed protein (LE-HMF) or a powdered intact protein HMF (PI-HMF) as the control. The study population consisted of preterm infants ?33 weeks who were enterally fed HM. Infants were studied from the first day of HM fortification until day 29 or hospital discharge, whichever came first.A total of 147 preterm infants were enrolled. Noninferiority was observed in weight gain reported in the intent-to-treat (ITT) analysis was 18.2 and 17.5 g · kg(-1) · day(-1) for the LE-HMF and PI-HMF groups, respectively. In an a priori defined subgroup of strict protocol followers (n?=?75), the infants fed LE-HMF achieved greater weight over time than those fed PI-HMF (P?=?0.036). The LE-HMF group achieved greater linear growth over time compared to the PI-HMF (P?=?0.029). The protein intake from fortified HM was significantly higher in the LE-HMF group compared with the PI-HMF group (3.9 vs 3.3 g · kg(-1) · day(-1), P?18 g · kg(-1) · day(-1).

SUBMITTER: Kim JH

PROVIDER: S-EPMC4645956 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.

Kim Jae H JH Chan Gary G Schanler Richard R Groh-Wargo Sharon S Bloom Barry B Dimmit Reed R Williams Larry L Baggs Geraldine G Barrett-Reis Bridget B

Journal of pediatric gastroenterology and nutrition 20151201 6

<h4>Objectives</h4>This study was a comparison of growth and tolerance in premature infants fed either standard powdered human milk fortifier (HMF) or a newly formulated concentrated liquid that contained extensively hydrolyzed protein.<h4>Methods</h4>This was an unblinded randomized controlled multicenter noninferiority study on preterm infants receiving human milk (HM) supplemented with 2 randomly assigned HMFs, either concentrated liquid HMF containing extensively hydrolyzed protein (LE-HMF) ...[more]

PMID: 26488118

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Project description:BackgroundIn case of cow's milk allergy (CMA), pediatric guidelines recommend for children the use of extensively hydrolyzed formulas (eHFs) as elimination diet. According to the American Academy of Pediatrics, the hypoallergenicity of each specific eHF should be tested in subjects with CMA.MethodsA prospective, multicenter trial was performed to assess the tolerance/hypoallergenicity of a thickened casein-based eHF (eHCF, Allernova AR®, United Pharmaceuticals, France) in infants aged <12 months with CMA proven by a double-blind placebo-controlled food challenge. Its efficacy, measured through allergy symptoms monitoring and Cow's Milk-related Symptom Score (CoMiSS) calculation, and safety were evaluated during a 4-month feeding period. Growth z-scores were computed based on WHO anthropometric data.ResultsThirty infants (mean age: 4.8 ± 3.0 months) with CMA proven by a DBPCFC tolerated the eHCF during the 4-month study. The CoMiSS, crying and regurgitation scores significantly decreased by 4.2 ± 4.0, 0.9 ±1.2 and 0.7 ± 1.1 respectively, after 14 days of feeding (p < 0.001). The Scoring Atopic Dermatitis index, of 33.2 ± 14.8 at inclusion in 9 patients, significantly decreased by 15.5 ± 6.7 and 21.1 ± 11.2, after 14 and 45 days of feeding, respectively (p < 0.001). The percentage of infants having normal stool consistency (soft or formed stools) significantly improved from 66.7 % (20/30) at inclusion to 90.0 % (27/30) after 14 days of feeding (p = 0.020). The growth z-scores, negative at study inclusion, significantly improved over the 4-month study. No adverse event was related to the eHCF.ConclusionThe thickened eHCF was tolerated by more than 90 % of included allergic infants with 95 % confidence interval and can therefore be considered as hypoallergenic in accordance with current guidelines. The improvement of growth indices and absence of related adverse events confirmed its safety. Results of this trial back the use of the tested thickened eHCF as an efficient and safe alternative in children with CMA.Trial registrationClinicalTrials.gov, number NCT02351531 , registered on 27 January 2015.

Project description:BackgroundOptimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein.MethodsIn this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 107 CFU Lactobacillus rhamnosus GG/100 kcal. Anthropometrics were measured and recall of formula intake, tolerance, and stool characteristics was collected at 14, 30, 60, 90, 120 days of age. Primary outcome was weight growth rate (g/day) between 14 and 120 days of age (analyzed by ANOVA). Medically confirmed adverse events were recorded throughout the study.ResultsNo group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups.ConclusionsThis study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age.Trial registrationClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366 . Registered 13 May 2011.

Dataset Information

Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.

Publications

Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.

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