Trial reportThe American journal of clinical nutrition2025
Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial.
Trial report in The American journal of clinical nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05525585 (Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants), which is not on this map. Cited by 2 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.
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial
Who cites it
2 citing papers in PubMed.
- Enteral nutrition in neonates: current evidence from clinical trials and evolving strategies.Seminars in perinatology · 2026Review
- Exclusive enteral nutrition in preterm infants: How early is too early?Seminars in fetal & neonatal medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundIn preterm infants, the timing of human milk fortification when maternal or donor milk is offered at volumes of 60-80 mL/kg/d within the first 36 h after birth remains a matter of debate.
objectivesThis trial assessed the impact of early human milk fortification (<7 d postnatal age) on fat-free mass (FFM) z-scores.
methodsThis was an unmasked clinical trial involving preterm infants with birthweight <1800 g and gestational ages ranging from 29 0/7 to 33 6/7 weeks of gestation. Human milk-fed infants receiving feeding volumes of 60-80 mL/kg/d within the first 36 h after birth were randomly assigned to receive either early (between days 4 and 7) or delayed (between days 10 and 14) fortification using a bovine-derived fortifier. FFM was assessed at postnatal day 21 using air-displacement plethysmography.
resultsA total of 80 infants were randomly assigned. The mean birthweight was 1488 g (SD: 233). Baseline characteristics did not differ between groups. Of 80 infants randomly assigned shortly after birth, 74 had the primary outcome measured at ∼35 wk of postmenstrual age (interquartile range: 34-36). No statistically significant differences in FFM z-scores were observed between the 2 groups (-1.7 ± 0.9 compared with -1.8 ± 0.9; P = 0.64), but the early fortification group had higher weight [median difference: +131 g; 95% confidence interval (CI): 12, 236; P = 0.03], higher FFM (median difference: +103 g; 95% CI: 1, 193; P = 0.03), and higher length (mean difference: +0.9 cm; 95% CI: 0.1, 1.8; P = 0.04) at the time of body composition assessment.
conclusionsIn very preterm infants receiving early full enteral nutrition, providing early human milk fortification does not result in higher than usual FFM z-scores. This feeding strategy may, however, lead to a sustained increase in length, and transient increases in weight and FFM in grams. This study was registered at clinicaltrials.gov as NCT05525585.
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