Trial reportArchives of disease in childhood. Fetal and neonatal edition2025
A novel human milk fortifier supports adequate growth in very low birth weight infants: a non-inferiority randomised controlled trial.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03315221 (Renoir), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Who cites it
4 citing papers in PubMed.
- Trial
- Recent trends in encapsulated bioactives for improving the delivery of infant milk fortifiers.Food science of animal resources · 2026Review
- Amino acids and lean mass accretion in preterm neonates.Current opinion in clinical nutrition and metabolic care · 2026Review
- Risk factors of necrotizing enterocolitis in very low birth weight infants: a meta-analysis.Frontiers in pediatrics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
designDouble-blind, randomised controlled trial.
settingNine European neonatal intensive care units. PATIENTS: HM-fed infants born at <32-week gestational age.
interventionsFortification of HM with Test or Control HMF for a minimum of 21 days. PRIMARY OUTCOME: Weight growth velocity between baseline and intervention day 21.
resultsFrom 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).
conclusionsUse 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.
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