Official Title
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Phase
Phase 2Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
SepsisIntervention/Treatment
lactobacillus plantarum ...Study Participants
284India, 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.
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a day for the first 7 days of life. The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates.
GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.
Newborn infants' ≥ 35 weeks of gestation and ≥1800g, given L. plantarum preparations orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.
Newborn infants' ≥ 35 weeks of gestation and ≥1800g, receiving placebo preparations (a control solution of sterile 2.0 cc 5% dextrose-saline)orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.
Inclusion Criteria: Infants ≥ 35 weeks and ≥1800g born in the hospital Infants > 12 hours and < 72 hours of age at enrollment Infants likely to be hospitalized for 5-7 days without antibiotic treatment Informed consent by one parent or guardian Infants begun breastfeeding Exclusion Criteria: Antibiotic therapy prior to enrollment Evidence or suspicion of clinical sepsis before randomization Inability (as determined by the physician) to tolerate oral feeding of study supplement Presence of major congenital anomalies Infant's home is >30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
