Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0 –2-month-old low birth weight infants in India—the “ProSPoNS” Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial

DiscussionThis adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low –middle-income countries.Trial registrationClinical Trial Registry of India (CTRI)CTRI/2019/05/019197. Registered on 16 May 2019
Source: Trials - Category: Research Source Type: clinical trials