Prevention of Infection in Indian Neonates - Phase II Probiotics Study

NICHD Global Network for Women's and Children's Health

Status and phase: Completed; Phase 2

Conditions: Sepsis

Treatments: Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00518596

U01HD040574 (U.S. NIH Grant/Contract)

GN 07 Phase II

R01HD053719 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: Under 72 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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284 participants in 2 patient groups, including a placebo group

Probiotic Arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)