Effect of oral Vitamin A Supplementation in tiny babies.
Not Applicable
Completed
- Conditions
- Health Condition 1: P271- Bronchopulmonary dysplasia originating in the perinatal periodHealth 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
- Registration Number
- CTRI/2017/03/008131
- Lead Sponsor
- Sriparna Basu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
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
1. Major congenital malformation including gastro-intestinal (GI) tract anomalies
2. Any life threatening condition where oral feeding is contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined incidence of death within 28 days and duration of oxygen requirementTimepoint: Primary outcome variable will be measured on day 28 of life
- Secondary Outcome Measures
Name Time Method 1. Safety and tolerability of vitamin A supplementation <br/ ><br>2. Serum retinol concentration at recruitment and at day 28 of life <br/ ><br>3. Total number of days on CPAP or mechanical ventilation <br/ ><br>4. Nosocomial infection <br/ ><br>5. Hemodynamically significant patent ductus arteriosus <br/ ><br>6. Necrotizing enterocolitis (Bell stage II and beyond) <br/ ><br>7. Intraventricular hemorrhage (Grade II and beyond) <br/ ><br>8. Periventricular leukomalacia <br/ ><br>9. Bronchopulmonary dysplasia <br/ ><br>10. Retinopathy of prematurityTimepoint: Secondary outcome variables will be measured on day 28 of life