Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
NCT ID: NCT00518596 Phase: PHASE2 Status: COMPLETED Enrollment: 284 Completion: 2006-08
Conditions
Sepsis
Interventions
Probiotic supplementation (Lactobacillus plantarum)
Summary
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Primary Outcome
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.