Health Condition 1: null- babies less than 2000 grams and admitted to NICU
Conditions
Interventions
Intervention1: Early administration of BCG: Children in the intervention group will be vaccinated with BCG and OPV as soon as possible after admission to the NICU - this will usually occur within a fe
Sponsors
JIPMER
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 followedup at 29 days (or soon after) to determine whether they survived to 28 days and whether they have been given 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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
India
Contacts
Public ContactDr B Vishnu Bhat
JIPMER
Outcome results
None listed