Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: BCG-Russia: Neonates will be vaccinated with BCG-Russia vaccine given within 24 hours of birth. Dose: 0.05 ml intradermal
Intervention2: BCG-Denmark: Neonates will be vaccinated with BC
Sponsors
Department of Paediatrics
Eligibility
Inclusion criteria
Inclusion criteria: 1. Neonates born at 30-35 weeks of gestation and admitted in NICU 2. Informed written consent obtained from parents
Exclusion criteria
Exclusion criteria: 1. Neonates born to mothers with: a. HIV, HBV or tuberculosis infection or receiving immunosuppressive medications b. Suspected triple-I (fever without a clear source with either baseline fetal tachycardia/maternal TLC >15000/mcl AND/OR definite purulent fluid from cervical os) or prolonged rupture of membranes >18 hours c. History of early neonatal death/family history of immunodeficiency 2. Neonates with severe birth asphyxia 3. Neonates with major congenital malformations 4. Parents who refuse to give informed consent/withdraw consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological profiles at baseline, 72 hours and at 7 days of life in preterm neonates vaccinated at birth with BCG-Russia and BCG-Denmark compared with neonates vaccinated later.Timepoint: At baseline, at 72 hours of life and at day 7 of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Scar rates in neonates vaccinated with BCG-Denmark and BCG-RussiaTimepoint: 12 weeks of life;Side effect profile of neonates vaccinated with BCG-Denmark and BCG-RussiaTimepoint: Day 0, Day 1, Day 3, Day 5, Day 7, day 14, day 28;Neonatal mortality rates in all three groupsTimepoint: Day 28 | — |
Countries
India
Contacts
Public ContactMudit Agarwal
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed