Delayed BCG Study (DBS): determining whether BCG vaccination might protect infants against non-tuberculous invasive infectious disease by stimulating the innate immune system
- Conditions
- All cause infectious diseaseInfections and Infestations
- Registration Number
- ISRCTN59683017
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine (UK)
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29655624 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25872925
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 560
Neonates born to women delivering in Entebbe Grade B or Kisubi hospitals will be eligible for inclusion if:
1. Mother consents for participation
2. They reside in the study catchment areas
3. Mothers are HIV negative (based on records available from antenatal care received during this pregnancy)
4. The birth was sufficiently uncomplicated to allow the neonate to be discharged directly home from hospital with no infant admission or treatment for complications
5. The neonate is of a gestational age and birth weight to allow discharge directly home from hospital (no requirement for supplemental oxygen or feeding)
Neonates will be excluded from the study if:
1. Cord blood is not obtained
2. They have major congenital malformations
3. The infant is clinically unwell, as judged by a midwife
4. Known maternal tuberculosis (TB) or active TB within the family (based on direct questioning of mother during recruitment)
5. Maternal or family member positive for any TB screening symptoms:
5.1. Cough > 2 weeks
5.2. Recent haemoptysis
5.3.>3 kg weight loss in past month
5.4. Recurrent fevers/chills or night sweats for the past 3 days or more
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method