Early Aggressive Enteral Feeding in Neonates Weighing 750-1250 Grams: A Randomized Controlled Trial.

BACKGROUND: In preterm neonates, enteral feeding is advanced slowly, considering the risk of necrotizing enterocolitis. Prolonged intravenous alimentation in these neonates, however, may increase the risk of sepsis-related morbidity and mortality, particularly in low resource settings. OBJECTIVES: Objective of this was study to evaluate impact of aggressive enteral feeding on mortality and morbidities among preterm neonates. DESIGN: Randomized controlled trial. PARTICIPANTS: Neonates with birthweight 750-1250 g. INTERVENTIONS: 131 preterm neonates with birth weight 750-1250 g, admitted to neonatal intensive care unit between April 2012 and June 2014, were randomized to aggressive feeding or conservative feeding regimen. OUTCOMES: The primary outcome of the study was all-cause mortality during hospital stay. The secondary outcomes included proportion of sepsis (blood culture proven), necrotizing enterocolitis, feed intolerance, survival without major morbidity at discharge, time to reach full enteral feed (180 mL/kg/d), duration of hospitalization, and average daily weight gain (g/kg). RESULTS: All-cause mortality was 33.3% in aggressive regimen and 43.1% in conservative regimen, [RR (95%) CI 0.77 (0.49, 1.20)]. Neonates with aggressive feeding regimen reached full enteral feed earlier; median (IQR) 7 (6, 8) days compared to conservative regimen, 10 (9, 14) days; P <0.001. There was no difference in culture positive sepsis rate, survival without major morbidities, feed intolerance, necrotizing enterocolitis, duration of hospitalization and average daily weight gain. CONCLUSIONS: In neonates with birth weight 750-1250 g, early aggressive feeding regimen is feasible but not associated with significant reduction in all-cause mortality, culture positive sepsis or survival without major morbidities during hospital stay. Neonates with aggressive regimen have fewer days on IV fluids and reach full feed earlier.