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-DE
- 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 (>2.5 / <10 ml/kg body weight per day) commenced.
Signed and dated informed parental or legal representative’s 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