A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5000 IU/kg/d versus placebo for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.
- Conditions
- P27.1Bronchopulmonary dysplasia originating in the perinatal period
- Registration Number
- DRKS00006541
- Lead Sponsor
- niversität des Saarlandes, Saarbrücken, Deutschland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 914
Neonates with a birth weight <1000 g
- Neonates with a gestational age < 32 + 0 weeks at time of inclusion into the trial
- Who receive any oxygen supplementation or respiratory support after Admission to the NICU within 72 hours following birth
- Who (will) receive a basic VA supplementation of 1000 IU/kg body weight/day
(7000 IU/kg body weight/week)
- Postnatal age <72 hours of life
- Minimal/enteral feeds commenced
- Signed and dated informed parental consent
- =1 major congenital abnormalities
- Congenital nonbacterial infection with overt signs at birth
- Terminal illness as evidenced by pH <7.0 for >2 hours or persistent bradycardia (heart rate <100 bpm) associated with hypoxia for >2 hours
- Birth weight <400 g
- Participation in another clinical trial according to German Drug Law (AMG)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined Incidence of BPD (moderate/severe) or death at 36+0 weeks PMA or at date of discharge to home, whichever comes first.
- Secondary Outcome Measures
Name Time Method