Health Condition 1: P271- Bronchopulmonary dysplasia originating in the perinatal period Health Condition 2: null- Very low birth weight (birth weight less than 1500 g) neonates requiring respiratory support in the form of oxygen inhalation, CPAP or mechanical ventilation at 24 h of age
Conditions
Interventions
Intervention1: Vitamin A: Alternate day oral administration of 1 ml syrup vitamin A, containing 10000 IU of retinol per ml for 28 days (total 14 doses).
Control Intervention1: Placebo: Alternate day
Sponsors
Sriparna Basu
Parul Khanna second investigator
Eligibility
Inclusion criteria
Inclusion criteria: Inborn, very low birth weight (birth weight less than 1500 g) neonates with respiratory distress requiring respiratory support in the form of oxygen inhalation, CPAP or mechanical ventilation at 24 hours of age.
Exclusion criteria
Exclusion criteria: 1. Major congenital malformation including gastro-intestinal (GI) tract anomalies 2. Any life threatening condition where oral feeding is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined incidence of death within 28 days and duration of oxygen requirementTimepoint: Primary outcome variable will be measured on day 28 of life | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability of vitamin A supplementation 2. Serum retinol concentration at recruitment and at day 28 of life 3. Total number of days on CPAP or mechanical ventilation 4. Nosocomial infection 5. Hemodynamically significant patent ductus arteriosus 6. Necrotizing enterocolitis (Bell stage II and beyond) 7. Intraventricular hemorrhage (Grade II and beyond) 8. Periventricular leukomalacia 9. Bronchopulmonary dysplasia 10. Retinopathy of prematurityTimepoint: Secondary outcome variables will be measured on day 28 of life | — |
Countries
India
Contacts
Public ContactSriparna Basu
Dept of Pediatrics, Institute of Medical Sciences Banaras Hindu University, Varanasi, India
Outcome results
None listed