A randomized controlled trial in preterm infants comparing prophylactic with selective Less Invasive Surfactant Administration”
Phase 3
Recruiting
- Conditions
- P22.0Respiratory distress syndrome of newborn
- Registration Number
- DRKS00028086
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein Campus Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 698
Inclusion Criteria
1) Preterm infants with a gestational age between 25 weeks + 0 days and 28 weeks + 6 days,
(2) age <= 60 minutes,
(3) spontaneous breathing on continuous positive airway pressure (CPAP) with supplemental oxygen < 30%.
Exclusion Criteria
(1) Lethal malformations, (2) planned comfort care
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint of this study is the FEV1 at the age of 5 years. FEV1 will be determined with the help of the ‘Global Lung Function Initiative’ (GLI) (Quanjer et al. 2012).
- Secondary Outcome Measures
Name Time Method 1. FVC in z-score<br>2. Ratio of FEV1 and FVC in z-score (FEV1/FVC )<br>3. Length in m of running track in 3 minutes running test<br>4. Cerebral palsy, defined as Gross Motor Function Classification System value > 1<br>5. Score in Movement Assessment Battery for Children<br>6. Intelligence, assessed by Wechsler Preschool and Primary Scale of Intelligence (WPPSI) IV<br>7. Obstructive bronchitis (treated with inhaled or other drugs) in the last 12 months<br>