Efficacy of Probiotics Versus Placebo in the Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double-Blind Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis (NEC) in preterm very low birth weight (VLBW) infants.

STUDY DESIGN: Arandomized double blind controlled trial.

PLACE AND DURATION OF STUDY: The Paediatrics Department of Sylhet M.A.G. Osmani Medical College Hospital, Sylhet Bangladesh, from July 2012 to June 2015.

METHODOLOGY: Preterm (28 - 33 weeks gestation) VLBW (birth weight 1000 - 1499 g) neonates were enrolled. The study group was fed with probiotics once daily with breast milk from first feeding, and the control group with only breast milk without the addition of probiotics. Both the groups received other standard care. The primary outcome was the development of NEC (stage II and III), categorized by modified Bell's classification.

RESULTS: In 108 neonates, development of NEC was significantly lower in the study group than that of control group [1 (1.9%) vs. 6 (11.5%); p=0.044]. Age of achievement of full oral feeding was significantly earlier in the study group than that in the control group (14.88 ±3.15 and 18.80 ±4.32 days; p < 0.001). Duration of hospital stay was significantly short in the study group compared to the control group (15.82 ±2.94 days vs. 19.57 ±4.26 days; p < 0.001).

CONCLUSION: Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight. It is also associated with faster achievement of full oral feeding and short duration of hospital stay.