Prevention of Infection in Indian Neonates - Phase II Probiotics Study

NICHD Global Network for Women's and Children's Health284 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

284

Conditions

Sepsis

Interventions

Probiotic supplementation (Lactobacillus plantarum)DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMax age: 72 HoursHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Capital Hospital

Bhubaneswar, Odisha, India

Kalinga Hospital

Bhubaneswar, Odisha, India

Ispat General Hospital

Rourkela, Odisha, India

Outcomes

Primary Outcomes

Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.

Time frame: 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.

Time frame: 28 days

Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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