Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: A Randomized, Double-blind, Placebo-controlled Pilot Trial

Objective: To study the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants. Study Design: Randomized, double-blind, placebo-controlled pilot trial. Participants: Neonates with birth weight <= 1500 g, gestation <= 32 weeks and postnatal age <= 96 h. Intervention: Enteral bovine colostrum or placebo, four times a day, till 21 days of life or discharge or death. Main outcome measures: Definite NEC. Secondary outcomes included sepsis, mortality and stool interleukin-6 (IL-6) levels. Results: Of the total 86 subjects (43 in each group), there were no statistically significant in the main outcome measures. In the colostrum group, there were trends toward higher stool IL-6 values and higher incidence of ileus and radiological signs of NEC. Conclusion: The use of prophylactic enteral bovine colostrum in VLBW infants shows a trend toward increased stool IL-6 and features of NEC. We were unable to detect clinical benefits.