To study the efficacy and safety of early (at birth) versus late (34 weeks gestation) BCG vaccination in preterm babies born between 31-33 weeks gestatio
Not Applicable
- Conditions
- Health Condition 1: null- Moderately preterm Appropriate for Gestational age babies(31-33 weeks)
- Registration Number
- CTRI/2013/09/004019
- Lead Sponsor
- niversity College of Medical Sciences and Guru Tegh Bahadur Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
The study shall include preterm AGA babies 31-33 weeks residing <10 km of GTBH and can be contacted whenever required
Exclusion Criteria
Babies of mothers suffering from tuberculosis or receiving antitubercular drugs eclampsia chronic infection severe anaemia known cases HIV positive, Hepatitis B positive Babies having clinical evidence of intrauterine infection undergoing exchange transfusion receiving blood or blood products severe birth asphyxia critically ill babies septicaemia. (3) Babies with congenital anomalies and or clinical suspicion of chromosomal disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Purified protein derivative conversion by Mantoux test (induration 5-9 mm) rate at monthsTimepoint: Purified protein derivative conversion by Mantoux test (induration 5-9 mm) rate at 6 months
- Secondary Outcome Measures
Name Time Method a)Four-fold rise in interferon-gamma levels in serum from baseline levels. <br/ ><br>b)BCG take up as measured by proportion of infants with local reaction and maximum transverse diameter of BCG scar. <br/ ><br>c)Complications of BCG vaccine <br/ ><br>Timepoint: 6, 10 and 14weeks <br/ ><br>6 months