â??Beneficial non-specific effects of BCG-Green signal and zero dose polio on neonatal survival in babies less than 2000 gram.
Not Applicable
- Conditions
- Health Condition 1: P071- Other low birth weight newborn
- Registration Number
- CTRI/2018/08/015424
- Lead Sponsor
- Chinnathambi Kamalarathnam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
all babies weighing less than 2000 grams at the time of admission to NIC
Exclusion Criteria
1) Babies less than 60 minutes of age
(2) Babies not likely to survive more than 24 hours
(3) Babies older than 21 days of age
(4) Babies with a major life-threatening malformation
5) Mother or baby is known to have HIV, hepatitis B, herpes zoster or immuno-deficiency
(6) Baby has already received BCG
(7) Family refuses consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint for the trial will be mortality up to 28 days of age with censoring at the time of loss to follow-up or any vaccination (other than BCG-Green Signal and OPV in the BCG group), and adjusted for age at the time of randomization, survival dependence between twins, and for birth weight, gestation, sex, season, and whether the baby was inborn or out bornTimepoint: 0 to 28 days
- Secondary Outcome Measures
Name Time Method Time from randomization to death in the first 28 days of life. Both the primary and secondary endpoints will be analyzed separately for babies of mothers with and without a BCG scar.Timepoint: 0 to 28 days