Early and exclusive enteral nutrition in infants born very preterm.

Objective: To characterise the effects of early and exclusive enteral nutrition with either maternal or donor milk in infants born very preterm (28 ^0/7 -32 ^6/7 weeks of gestation).
Design: Parallel-group, unmasked randomised controlled trial.
Setting: Regional, tertiary neonatal intensive care unit.
Participants: 102 infants born very preterm between 2021 and 2022 (51 in each group).
Intervention: Infants randomised to the intervention group received 60-80 mL/kg/day within the first 36 hours after birth. Infants randomised to the control group received 20-30 mL/kg/day (standard trophic feeding volumes).
Main Outcome Measures: The primary outcome was the number of full enteral feeding days (>150 mL/kg/day) in the first 28 days after birth. Secondary outcomes included growth and body composition at the end of the first two postnatal weeks, and length of hospitalisation.
Results: The mean birth weight was 1477 g (SD: 334). Half of the infants were male, and 44% were black. Early and exclusive enteral nutrition increased the number of full enteral feeding days (+2; 0-2 days; p=0.004), the fat-free mass-for-age z-scores at postnatal day 14 (+0.5; 0.1-1.0; p=0.02) and the length-for-age z-scores at the time of hospital discharge (+0.6; 0.2-1.0; p=0.002). Hospitalisation costs differed between groups (mean difference favouring the intervention group: -$28 754; -$647 to -$56 861; p=0.04).
Conclusions: In infants born very preterm, early and exclusive enteral nutrition increases the number of full enteral feeding days. This feeding practice may also improve fat-free mass accretion, increase length and reduce hospitalisation costs.
Trial Registration Number: NCT04337710.
Competing Interests: Competing interests: AAS has a patent for an instrumented feeding bottle. Additionally, AAS has provided scientific advice to Resbiotic, received consulting fees for participating in advisory board meetings for Reckitt/Mead Johnson Nutrition and received speaking fees for participating in educational activities organised by p-value communications and WebMD.
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