Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial.

Details

Ressource 1Download: 28727654_BIB_172D94E47187.pdf (351.92 [Ko])
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_172D94E47187
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial.
Journal
Journal of pediatric gastroenterology and nutrition
Author(s)
Rigo J., Hascoët J.M., Billeaud C., Picaud J.C., Mosca F., Rubio A., Saliba E., Radkë M., Simeoni U., Guillois B., de Halleux V., Jaeger J., Ameye L., Hays N.P., Spalinger J.
ISSN
1536-4801 (Electronic)
ISSN-L
0277-2116
Publication state
Published
Issued date
10/2017
Peer-reviewed
Oui
Volume
65
Number
4
Pages
e83-e93
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Abstract
The aim of this study was to assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid.
In this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days. Weight gain was evaluated for noninferiority (margin = -1 g/day) and superiority (margin = 0 g/day). Nutritional status and gut inflammation were assessed by blood, urine, and fecal biochemistries. Adverse events were monitored.
Adjusted mean weight gain (analysis of covariance) was 2.3 g/day greater in nHMF versus cHMF; the lower limit of the 95% CI (0.4 g/day) exceeded both noninferiority (P < 0.001) and superiority margins (P = 0.01). Weight gain rate (unadjusted) was 18.3 (nHMF) and 16.8 g · kg · day (cHMF) between study days 1 and 21 (D1-D21). Length and head circumference (HC) gains between D1 and D21 were not different. Adjusted weight-for-age z score at D21 and HC-for-age z score at week 40 corrected age were greater in nHMF versus cHMF (P = 0.013, P = 0.003 respectively). nHMF had higher serum blood urea nitrogen, pre-albumin, alkaline phosphatase, and calcium (all within normal ranges; all P ≤ 0.019) at D21 versus cHMF. Both HMFs were well tolerated with similar incidence of gastrointestinal adverse events.
nHMF providing more protein and fat compared to a control fortifier is safe, well-tolerated, and improves the weight gain of preterm infants.

Keywords
Biomarkers/metabolism, Dietary Fats, Dietary Proteins, Double-Blind Method, Female, Food, Fortified, Humans, Infant Care/methods, Infant Nutritional Physiological Phenomena, Infant, Newborn, Infant, Premature/growth & development, Infant, Premature/metabolism, Infant, Very Low Birth Weight/growth & development, Infant, Very Low Birth Weight/metabolism, Male, Milk, Human, Nutrition Assessment, Nutritional Status, Outcome Assessment (Health Care), Weight Gain
Pubmed
Web of science
Create date
16/10/2017 16:29
Last modification date
20/08/2019 12:46
Usage data