Open AccessGrowth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier
Author(s) -
Rigo Jacques,
Hascoët JeanMichel,
Billeaud Claude,
Picaud JeanCharles,
Mosca Fabio,
Rubio Amandine,
Saliba Elie,
Radkë Michaël,
Simeoni Umberto,
Guillois Bernard,
Halleux Virginie,
Jaeger Jonathan,
Ameye Laurent,
Hays Nicholas P.,
Spalinger Johannes
Publication year - 2017
Publication title -
journal of pediatric gastroenterology and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 131
eISSN - 1536-4801
pISSN - 0277-2116
DOI - 10.1097/mpg.0000000000001686
Subject(s) - medicine , randomized controlled trial , weight gain , gastroenterology , infant formula , adverse effect , zoology , pediatrics , body weight , biology
Objectives: 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. Methods: 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. Results: 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 −1 · day −1 (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. Conclusions: nHMF providing more protein and fat compared to a control fortifier is safe, well‐tolerated, and improves the weight gain of preterm infants.