Prevention of Infection in Indian Neonates - Phase II Probiotics Study

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.

Conditions

• Sepsis

Interventions

DIETARY_SUPPLEMENT

Probiotic supplementation (Lactobacillus plantarum)

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.

Sponsors & Collaborators

• Global Network for Women's and Children's Health Research

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• RTI International

  collaborator OTHER

• All India Institute of Medical Sciences

  collaborator OTHER

• TN Medical College, Mumbai

  collaborator OTHER

• Department of Health and Family Welfare, Orissa

  collaborator OTHER

• SCB Medical College, Cuttack

  collaborator OTHER

• Capital Hospital, Bhubaneswar

  collaborator OTHER

• Ispat General Hospital, Rourkela

  collaborator OTHER

• Kalinga Hospital, Bhubaneswar

  collaborator OTHER

• University of Maryland

  collaborator OTHER

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

  lead NETWORK

Principal Investigators

• Pinaki Panigrahi, M.D. · University of Maryland, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-07-31

Completion

2006-08-31

Countries

• India

Study Locations