Prevention of Infection in Indian Neonates - Phase II Probiotics Study
- Conditions
- Sepsis
- Interventions
- Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)
- Registration Number
- NCT00518596
- Lead Sponsor
- NICHD Global Network for Women's and Children's Health
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Arm Probiotic supplementation (Lactobacillus plantarum) 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. Control Arm Probiotic supplementation (Lactobacillus plantarum) 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.
- Primary Outcome Measures
Name Time Method Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration. 28 days Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates. 28 days Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
- Secondary Outcome Measures
Name Time Method Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).
Trial Locations
- Locations (3)
Capital Hospital
🇮🇳Bhubaneswar, Orissa, India
Kalinga Hospital
🇮🇳Bhubaneswar, Orissa, India
Ispat General Hospital
🇮🇳Rourkela, Orissa, India