Effect of Extended Infusion versus Intermittent Bolus Feedings on Hospital Weight Gain in Extremely Low Birth Weight Infants Born at <29 Weeks of Gestation: A Randomized Non-Inferiority Clinical Trial.

Abstract

To evaluate if extended infusion based enteral feeding was non-inferior to intermittent bolus feeding for hospital weight gain in infants born at extremely low birth weight (ELBW). Infants with ELBW and born at <29 weeks of gestation on minimal enteral nutrition were randomized to feeding advancements as extended milk infusion feeding (5-hour continuous milk infusion followed by 1-hour feeding break) or every 2 hour intermittent bolus feeding. The infusion feeding continued until a postmenstrual age of 30 weeks or postnatal weight of 1.2 kg. The primary outcome was in-hospital weight gain (g/kg/day) assessed using 2-point average model with a non-inferiority margin of -2. We randomized 132 infants (infusion, n=68; bolus, n=64). The median gestational age and birth weight were 26.4 ± 1.2 weeks and 752 ± 140 grams. The infusion group received infusion feedings for an average of 47 days (IQR: 44-53). The median time to full enteral feedings was similar (infusion: 10 days [IQR: 7-12]; bolus: 9 days [IQR: 7-12], P =.82]. The mean (SD) rate of weight gain at discharge was 15.3 ± 2.6 g/kg/day versus 15.7 ± 2.8 g/kg/day (mean difference, -0.4 g/kg/day, lower limit of the one sided 97.5% confidence interval: -1.15g/kg/day, per protocol analysis). The infusion group had significantly fewer days of feedings interruptions (6.7 days [5.6-8.1] vs 8.7 [7.4-10.1] per 100 patient days, P =.03) in the first 28 days. Duration of hospitalization and morbidities were similar in study groups. Among infants with ELBW that achieve early enteral feedings, extended infusion feeding was non-inferior to bolus feedings for hospital weight gain.