Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy of Probiotic Supplementation for Prevention of Neonatal Sepsis in 0-2 Months old Low Birth Weight Infants in India (The 'ProSPoNS' Study)

Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. A multi-center study with 6144 infants randomized to receive Vivomixx probiotic or a placebo. Findings: The incidence of PSBI was significantly lower in the probiotic than the placebo group (4.66% vs. 6.17%), representing a 25% relative risk reduction. Daily probiotic supplementation significantly reduced the incidence of PSBI in LBW infants, supporting its role as a safe and effective infection prevention strategy in community settings within LMICs.