Clinical trial NCT00518596: Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Official title: Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Keywords: Neonatal
Sepsis
Global Network
Probiotics
India
International
Maternal and child health
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: Fogarty International Center of the National Institute of Health
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Cancer Institute (NCI)
name: RTI International
name: All India Institute of Medical Sciences
name: TN Medical College, Mumbai
name: Department of Health and Family Welfare, Orissa
name: SCB Medical College, Cuttack
name: Capital Hospital, Bhubaneswar
name: Ispat General Hospital, Rourkela
name: Kalinga Hospital, Bhubaneswar
name: University of Maryland
First posted: 2007-08-21
Enrollment: 284
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
Secondary outcomes:
measure: 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).
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Capital Hospital
state: Orissa
city: Bhubaneswar
country: India
facility: Kalinga Hospital
state: Orissa
city: Rourkela
country: India
facility: Ispat General Hospital
state: Orissa
Study officials:
affiliation: University of Maryland, Baltimore
name: Pinaki Panigrahi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: