Does BCG vaccine prevent death from infections other than tuberculosis in low-birth-weight babies.
Not Applicable
- Conditions
- Health Condition 1: null- babies less than 2000 grams and admitted to NIC
- Registration Number
- CTRI/2014/03/004450
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 2426
Inclusion Criteria
All babies weighing less than 2000 grams at the time of admission to Neonatal Intensive Care Unit (NICU)
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) the mother or baby is known to have HIV, hepatitis B, herpes zoster or immunodeficiency; (6) the baby has already received
BCG; or
(7) the family refuses consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality up to 28 days of age, or discharge (whichever is sooner); if <br/ ><br>possible, babies discharged home (or who leave against medical advice) before 28 days of age will be followedup <br/ ><br>at 29 days (or soon after) to determine whether they survived to 28 days and whether they have been given <br/ ><br>any vaccines.Timepoint: Mortality up to 28 days of age or discharge (whichever is sooner); if possible, babies discharged before 28 days of age will be followed-up at 29 days (or soon after) to determine whether they survived to 28 days and whether they have been given any vaccines
- Secondary Outcome Measures
Name Time Method (with censoring at the time of any vaccination other than BCG and OPV in the intervention group) mortality up to 28 days of age, time from randomisation to death or discharge in the first 28 days of life, (whichever is sooner). Randomisation and outcome data will be entered on paper and online. Initially, four babies will be recruited on a pilot basis to check the integrity of the processesTimepoint: (with censoring at the time of any vaccination other than BCG and OPV in the intervention group) mortality up to 28 days of age, time from randomisation to death or discharge in the first 28 days of life, (whichever is sooner). Randomisation and outcome data will be entered on paper and online. Initially, four babies will be recruited on a pilot basis to check the integrity of the processes