Prophylactic Probiotics for Prevention of Necrotizing Enterocolitis (NEC) in Low Birth Weight Neonates

Background: Probiotics are thought to interfere with the mechanisms involving in the pathogenesis of necrotizing enterocolitis in neonates. Objectives: This study was planned to assess the effect of prophylactic probiotics for the prevention of necrotizing enterocolitis in low birth weight neonates. Patients and Methods: This prospective triple-blinded, interventional, randomized clinical trial enrolled 136 low birth weight newborn infants with a minimum birth weight of 700 g, from September 2010 to September 2011. The study and control groups were compared regarding; 1 -occurrence of NEC, 2-time to reach full feeding, defined as days required to reach full enteral feeding, 3-duration of hospital course, and 4-incidence of sepsis and death. The study group was fed with milk and Protexin (restore) and the control group was fed with milk and a placebo that was physically indistinguishable from the probiotic powder. SPSS version 16 was used, and P-value less than 0.05 was considered significant. Results: One hundred thirty six neonates were enrolled in the study. Seventy six(54.4%) were male. The mean of gestational age and birth weight were 31 weeks and 1407 grams, respectively. The mean age to start feeding was 4.36 days. There was not any significant difference in the NEC cases between the two groups. Conclusions: This study did not show any benefit from prophylactic probiotics in the prevention of necrotizing enterocolitis in low birth weight neonates which could be probably due to low dose probiotics used.