Early progressive feeding in extremely preterm infants: a randomized trial

Abstract

Background: Due to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth.

Objective: The aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants.

Design: In this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access.

Results: Sixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups.

Conclusion: Early progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

Figures

FIGURE 1

Study enrollment, randomization, and outcomes. NEC, necrotizing enterocolitis; RDS, respiratory distress syndrome; SIP, spontaneous intestinal perforation.

FIGURE 2

Percentage of infants with full enteral feeding established according to the intervention group. In this time-to-event analysis, the observation period began at birth and continued until postnatal day 28. The number of infants eligible for or “at risk” of developing the outcome of interest (i.e., full enteral feeding) changed over time (numbers at the bottom of the graph). Infants removed from the study as a consequence of serious adverse events (i.e., necrotizing enterocolitis, spontaneous intestinal perforation, or death) were censored (not counted in the denominator used to report the percentage of infants with full enteral feeding established). Infants unable to achieve full enteral feeding by postnatal day 28 were also censored.