Health Condition 1: null- Babies less than 2000 grams and admitted to Neonatal Intensive Care Unit (NICU).
Conditions
Interventions
Intervention1: Early administration of BCG: Children in the intervention group will be vaccinated with BCG (BCG-Russia, Serum Institute of India, Pune) as soon as possible after admission to the NICU
Sponsors
Institute of Child Health and Hospital for Children
Eligibility
Inclusion criteria
Inclusion criteria: All babies weighing less than 2000 grams at the time of admission to Neonatal Intensive Care Unit (NICU)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality up to 28 days of age, or discharge (whichever is sooner); if possible, babies discharged home (or who leave against medical advice) 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.Timepoint: 28 days of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 28 days of age | — |
Countries
India
Contacts
Public ContactDr N Saravanan
Saveetha Medical College
Outcome results
None listed