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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00518596
First received: August 20, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
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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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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
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
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
| 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: | August 20, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Neonatal Sepsis Global Network Probiotics |
India International Maternal and child health |
Additional relevant MeSH terms:
|
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013