A randomised controlled trial in preterm infants comparing prophylactic with selective Less Invasive Surfactant Administration” (pro.LISA)
Phase 1
- Conditions
- Respiratory distress syndrome in preterm infantsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2024-516504-42-00
- Lead Sponsor
- niversitaetsklinikum Schleswig-Holstein AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 698
Inclusion Criteria
Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy, Age <= 60 minutes, Spontaneous breathing on CPAP, Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%, Written informed consent of the legal guardian(s) (retrospectively if necessary)
Exclusion Criteria
Malformations or diseases with a probable lethal outcome, Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride
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