A novel human milk fortifier supports adequate growth in very low birth weight infants: A non-inferiority randomised controlled trial

Picaud, Jean-Charles, Reynolds, Peter Robert, Clarke, Paul, van den Hooven, Edith, van Weissenbruch, Mirjam M., van Lingen, Richard A., Goedhart, Annemiek, Botma, Akke, Boettger, Ralf, van Westering-Kroon, Elke, Fusch, Christoph and Hascoet, J. M. and The Renoir Study Group (2025) A novel human milk fortifier supports adequate growth in very low birth weight infants: A non-inferiority randomised controlled trial. Archives of Disease in Childhood - Fetal and Neonatal Edition. ISSN 1359-2998

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Abstract

Objective: To compare growth, tolerance and safety parameters in very preterm infants receiving human milk (HM) fortified with a multicomponent cow’s milk-based HM fortifier (HMF; control) versus a novel HMF-containing lipids (including docosahexaenoic acid and arachidonic acid), higher protein and lower carbohydrate levels (test). Our hypothesis was that weight growth velocity in the test group would be non-inferior to that in the control group. Design: Double-blind, randomised controlled trial. Setting: Nine European neonatal intensive care units. Patients: HM-fed infants born at <32-week gestational age. Interventions: Fortification of HM with Test or Control HMF for a minimum of 21 days. Primary outcome: Weight growth velocity between baseline and intervention day 21. Results: From March 2018 to July 2020, 102 and 103 infants were enrolled in the test and control groups, respectively. Weight growth velocity during the first 21 days in the test group (mean 18.4 g/kg/day) was non-inferior to that of controls (mean 18.5 g/kg/day), with a difference in estimated means of –0.175 g/kg/day (90% CI –1.34 to +0.99 g/kg/day; per-protocol population). No significant differences between groups were observed for gain in length, head circumference or anthropometric Z-scores. Rates of digestive intolerance, stool frequency and consistency were comparable. No significant differences were reported in common neonatal morbidities including necrotising enterocolitis (test: 2.9%, control: 6.9%, mean difference –4.0% (95% CI –11.1% to 2.2%); all subjects treated population). Conclusions: Use of the novel HMF containing lipids, higher protein and lower carbohydrate levels supports adequate postnatal growth and appears safe and well tolerated in very preterm infants. Trial registration number: NCT03315221

Item Type:	Article
Additional Information:	Data availability statement: Data are available upon reasonable request. Reasonable requests for access to the data that support the findings of this study will be considered by contacting the Sponsor. Qualified researchers are required to submit a research proposal which is subject to a critical appraisal of compliance with the Danone Nutricia Research (DNR) Clinical Study Data Sharing policy and approved by a dedicated DNR review committee. Proposals should be directed to datasharing.clinicalresearchnutricia@danone.com. To gain access, data requestors will need to sign a data access agreement. Data are available for the period defined in the data access agreement. Funding information: The study Sponsor, Nutricia Research B.V., provided the funding to conduct the study.This work was supported by Nutricia Research B.V.
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
Related URLs:	https://fn.bmj.com/lookup/doi/10.1136/ar...
Depositing User:	LivePure Connector
Date Deposited:	07 Mar 2025 11:30
Last Modified:	10 Mar 2025 12:30
URI:	https://ueaeprints.uea.ac.uk/id/eprint/98711
DOI:	10.1136/archdischild-2024-327282

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