A clinical trial to study whether probiotics vsl#3 can prevent the occurrence of neonatal sepsis in low birth weight infants during 0-2 months of life.
Phase 2
Completed
- Registration Number
- CTRI/2008/091/000049
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1340
Inclusion Criteria
Eligibility: All live born LBW (>=1500 to ï?£ 2500 gms) babies available in the hospital would be eligible for the study if they have the following inclusion criteria.
1. Birth weight >=1500 gms to ï?£ 2500 gms, 2. Residence within 15-20 Kms of the hospital, 3.The mother is planning to stay in Delhi/ study area for a period of at least two months
Exclusion criteria: 1. Extreme prematurity ( <32 weeks) 2. Presence of a gross congenital malformation incompatible with life, 3. A mother who does not give consent, 4. mother going out of town with the baby.,
Exclusion Criteria
Extreme Prematurity 2. Presence of a gross congenital malformation incompatible with life,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method