Oral vitamin A supllementation versus placebo for preventing for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.
- Conditions
- Preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2013-001998-24-AT
- Lead Sponsor
- Saarland University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- =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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method