EUCTR2013-001998-24-AT
Active, not recruiting
Phase 1
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. - NeoVitaA
Saarland University0 sites914 target enrollmentJanuary 23, 2017
ConditionsPreventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsVitadral® Tropfen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.
- Sponsor
- Saarland University
- Enrollment
- 914
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- \=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)
Outcomes
Primary Outcomes
Not specified
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