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Prevention of Infection in Indian Neonates - Phase II Probiotics Study

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
All India Institute of Medical Sciences, New Delhi
TN Medical College, Mumbai
Department of Health and Family Welfare, Orissa
SCB Medical College, Cuttack
Capital Hospital, Bhubaneswar
Ispat General Hospital, Rourkela
Kalinga Hospital, Bhubaneswar
University of Maryland
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00518596
First received: August 20, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Sepsis
Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Infection in Indian Neonates - Phase II Probiotics Study

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

Enrollment: 284
Study Start Date: July 2005
Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: Probiotic Arm
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.
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.
Other Name: Gastroplan
Placebo Comparator: Control Arm
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.
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.
Other Name: Gastroplan

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

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518596

Locations
India
Capital Hospital
Bhubaneswar, Orissa, India
Kalinga Hospital
Bhubaneswar, Orissa, India
Ispat General Hospital
Rourkela, Orissa, India
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
All India Institute of Medical Sciences, New Delhi
TN Medical College, Mumbai
Department of Health and Family Welfare, Orissa
SCB Medical College, Cuttack
Capital Hospital, Bhubaneswar
Ispat General Hospital, Rourkela
Kalinga Hospital, Bhubaneswar
University of Maryland
Investigators
Principal Investigator: Pinaki Panigrahi, M.D. University of Maryland
  More Information

Additional Information:
No publications provided

Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00518596     History of Changes
Other Study ID Numbers: GN 07 Phase II, U01 HD040574
Study First Received: August 20, 2007
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Neonatal
Sepsis
Global Network
Probiotics
India
International
Maternal and child health

ClinicalTrials.gov processed this record on November 25, 2014