search
Back to results

Prevention of Infection in Indian Neonates - Phase II Probiotics Study

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Probiotic supplementation (Lactobacillus plantarum)
Sponsored by
NICHD Global Network for Women's and Children's Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis focused on measuring Neonatal, Sepsis, Global Network, Probiotics, India, International, Maternal and child health

Eligibility Criteria

undefined - 72 Hours (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Capital Hospital
  • Kalinga Hospital
  • Ispat General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 20, 2007
Last Updated
June 13, 2017
Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), 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
search

1. Study Identification

Unique Protocol Identification Number
NCT00518596
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), 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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Neonatal, Sepsis, Global Network, Probiotics, India, International, Maternal and child health

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplementation (Lactobacillus plantarum)
Other Intervention Name(s)
Gastroplan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Time Frame
28 days
Title
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
Title
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinaki Panigrahi, M.D.
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Hospital
City
Bhubaneswar
State/Province
Orissa
Country
India
Facility Name
Kalinga Hospital
City
Bhubaneswar
State/Province
Orissa
Country
India
Facility Name
Ispat General Hospital
City
Rourkela
State/Province
Orissa
Country
India

12. IPD Sharing Statement

Links:
URL
http://gn.rti.org
Description
Global Network for Women's and Children's Health Research
URL
http://www.rti.org
Description
RTI International
URL
https://projectreporter.nih.gov/project_info_description.cfm?aid=6332410&icde=33151915&ddparam=&ddvalue=&ddsub=&cr=7&csb=default&cs=ASC&pball=
Description
RePORTer link to abstract-U0-1 HD 40574 (Prevention of Infection in Indian Neonates)
URL
https://projectreporter.nih.gov/project_info_description.cfm?aid=7260679&icde=33151915&ddparam=&ddvalue=&ddsub=&cr=12&csb=default&cs=ASC&pball
Description
RePORTer link to abstract R0-1 HD 53719 (Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics)

Learn more about this trial

Prevention of Infection in Indian Neonates - Phase II Probiotics Study

We'll reach out to this number within 24 hrs