Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial
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Jacques Rigo1, Jean-Michel Hascoët, Claude Billeaud
1*Department of Neonatology, University of Liège, CHR Citadelle, Liège, Belgium †Maternité Régionale Universitaire A. Pinard, Nancy ‡CIC Pédiatrique 1401 INSERM-CHU, Bordeaux §Service de Neonatologie, Hôpital de la Croix Rousse, Lyon, France ||Neonatal Intensive Care Unit, Department of Clinical Science and Community Health, Fondazione IRCCS "Ca' Granda" Ospedale Maggiore Policlinico, University of Milan, Milan, Italy ¶Hôpital Couple Enfant, CHU de Grenoble, Grenoble #Hôpital Clocheville, CHU de Tours, Tours, France **Klinikum Westbrandenburg GmbH, Potsdam, Germany ††Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland ‡‡Hôpital Clemenceau, CHU de Caen, Caen, France §§Nestlé Clinical Development Unit, Lausanne, Switzerland ||||Nestlé Nutrition R&D, Vevey, Switzerland ¶¶Nestlé Nutrition R&D, King of Prussia, PA ##Children's Hospital of Lucerne, Lucerne, Switzerland.
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 · 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.
Conclusions:
nHMF providing more protein and fat compared to a control fortifier is safe, well-tolerated, and improves the weight gain of preterm infants.
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