Early and exclusive enteral nutrition in infants born very preterm

Abstract

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.

Keywords: Growth; Intensive Care Units, Neonatal; Neonatology.

Figure 1.. Flow diagram

From May 2021 to August 2022, 270 infants were born very preterm at the University of Alabama at Birmingham Hospital. Eighty-six families declined participation. Twenty-nine of these infants did not meet eligibility criteria. Thirty-one additional infants were not eligible due to concurrent enrollment in another feeding study. One hundred and two infants were consented and randomized. Two infants, one randomized to the control group and one randomized to the intervention group, were excluded from the data analysis after randomization due to postnatally diagnosed genetic anomalies. Two infants randomized to the intervention group (one of whom was also diagnosed with an excluding genetic anomaly) did not receive early and exclusive enteral nutrition due to clinical instability and ultimately died secondary to complications of their underlying diseases and were therefore excluded from analysis.