Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial
Abstract
BACKGROUND
In preterm infants, the timing of human milk fortification when maternal or donor milk is offered at volumes of 60-80 ml/kg/day within the first 36 hours after birth remains a matter of debate.
OBJECTIVE
This trial assessed the impact of early human milk fortification (< 7 days postnatal age) on fat-free mass (FFM) z-scores.
METHODS
This 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 gestation. Human milk-fed infants receiving feeding volumes of 60-80 ml/kg/day within the first 36 hours after birth were randomized to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification using a bovine-derived fortifier. FFM was assessed at postnatal day 21 using air-displacement plethysmography.
RESULTS
A total of 80 infants were randomized. The mean birthweight was 1488 g (SD: 233). Baseline characteristics did not differ between groups. Of 80 infants randomized shortly after birth, 74 had the primary outcome measured at approximately 35 weeks of postmenstrual age (IQR: 34 - 36). No statistically significant differences in FFM z-scores were observed between the two 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% 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;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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