Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial.
- Rigo J *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.
- Hascoët JM
- Billeaud C
- Picaud JC
- Mosca F
- Rubio A
- Saliba E
- Radkë M
- Simeoni U
- Guillois B
- de Halleux V
- Jaeger J
- Ameye L
- Hays NP
- Spalinger J
- 2017-07-21
Published in:
- Journal of pediatric gastroenterology and nutrition. - 2017
Biomarkers
Dietary Fats
Dietary Proteins
Double-Blind Method
Female
Food, Fortified
Humans
Infant Care
Infant Nutritional Physiological Phenomena
Infant, Newborn
Infant, Premature
Infant, Very Low Birth Weight
Male
Milk, Human
Nutrition Assessment
Nutritional Status
Outcome Assessment, Health Care
Weight Gain
English
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.
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.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1097/MPG.0000000000001686
- PMID 28727654
- Persistent URL
- https://sonar.rero.ch/global/documents/246366
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