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Lookup NU author(s): Dr Louise HayesORCiD, Dr Richard McNallyORCiD, Professor Janet Berrington, Professor Nicholas EmbletonORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2024. Background: Limited evidence exists on the preferred feeding method when breastfeeding is not possible in late and moderate preterm (LMPT) infants. This RCT evaluates growth, safety, and tolerance of a concept infant formula (IF) with large, milk phospholipid-coated lipid droplets enriched in dairy lipids in LMPT infants with primary objective to demonstrate non-inferiority of daily weight gain from randomization to 3 months corrected age compared to a standard IF. Methods: LMPT infants were randomized before or around term equivalent age to either the concept (n = 21) or standard IF (n = 20). Forty-one breastfed (BF) infants served as reference. Results: Due to unintended low recruitment, non-inferiority in daily weight gain could not be demonstrated for the Concept compared to the Control group, but was compared to the BF group. Other outcomes were similar between the formula groups, except for an apparent larger head circumference gain in the Concept group. No apparent differences in growth and body composition outcomes were observed between the Concept and BF reference groups. Conclusion: This small-scale study suggests the concept IF is a safe alternative for parents who choose IF to feed their LMPT infant. Larger trials are needed to better determine impacts on head growth or body composition. Impact: In a small group of late and moderate preterm infants, growth from randomization until 3 months corrected age of infants fed with a concept infant formula with large, milk phospholipid-coated lipid droplets was not -significantly different from infants fed a standard infant formula. Infants in the Concept group had non-significant larger gain in head circumference compared to the Control group; larger trials are needed to confirm this finding. Both formulas were well-tolerated, with no differences in adverse events. The concept formula is potentially a safe alternative for parents of moderate to late preterm infants who choose to use formula milk.
Author(s): Kakaroukas A, Abrahamse-Berkeveld M, Hayes L, McNally RJQ, Berrington JE, van Elburg RM, Embleton ND
Publication type: Article
Publication status: Published
Journal: Pediatric Research
Year: 2024
Pages: ePub ahead of Print
Online publication date: 18/09/2024
Acceptance date: 01/08/2024
Date deposited: 02/10/2024
ISSN (print): 0031-3998
ISSN (electronic): 1530-0447
Publisher: Springer Nature
URL: https://doi.org/10.1038/s41390-024-03476-x
DOI: 10.1038/s41390-024-03476-x
Data Access Statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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