Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy of Probiotic Supplementation for Prevention of Neona
Medical Research Council
Indian Council for Medical Res (ICMR)
Neonatal infections (pneumonia, septicaemia, meningitis) are responsible for more than a quarter of the 1 million neonatal deaths every year in India(1). Low Birth Weight (LBW) is a very important indirect cause of death in neonates, accounting for 40% to 80% of neonatal deaths (2-3). Management of neonatal sepsis with antibiotics faces the problem of drug resistance and immune-modulation/immune-potentiating with the use of probiotics may prove to be an option. Available evidence suggests a beneficial effect of probiotics treatment on reducing the incidence and all -cause mortality due to NEC (4-5.). In our pilot study supplementation with probiotics VSL#3 in LBW infants was associated with a non-significant overall 21% reduction in the risk of suspected sepsis (PSBI). In the post-hoc analyses using physician's diagnosis of sepsis as the outcome measure, there was a 33% overall reduction in risk of sepsis. However, in the un-prespecified sub-group of infants weighing 1.5-1.99 kg, there was a 100% reduction, with no cases observed in the group receiving probiotic supplementation (6). Following on from the evidence on VLBW and premature infants and based on the positive results of the above mentioned pilot study, we propose to test the hypothesis, with sufficient power and a precise definition of the outcome measure to conclusively evaluate the role of probiotics among LBW infants in a multicentre double blind placebo controlled trial.
3.3 Nutrition and chemoprevention / Research Grant