Health Condition 1: P071- Other low birth weight newborn
Conditions
Interventions
Intervention1: BCG Green Signal (originally derived from BCG Denmark)
: Low-birth-weight babies will receive BCG-Green Signal plus OPV as soon as possible after admission to NICU (BCG group)
Control
Sponsors
Chinnathambi Kamalarathnam
Eligibility
Inclusion criteria
Inclusion criteria: all babies weighing less than 2000 grams at the time of admission to 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) Mother or baby is known to have HIV, hepatitis B, herpes zoster or immuno-deficiency (6) Baby has already received BCG (7) Family refuses consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the trial will be mortality up to 28 days of age with censoring at the time of loss to follow-up or any vaccination (other than BCG-Green Signal and OPV in the BCG group), and adjusted for age at the time of randomization, survival dependence between twins, and for birth weight, gestation, sex, season, and whether the baby was inborn or out bornTimepoint: 0 to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to death in the first 28 days of life. Both the primary and secondary endpoints will be analyzed separately for babies of mothers with and without a BCG scar.Timepoint: 0 to 28 days | — |
Countries
India
Contacts
Public ContactChinnathambi Kamalarathnam
Institute of Child Health and Hospital for Children
Outcome results
None listed