CTIS2024-516504-42-00
Active, not recruiting
Phase 1
A randomised controlled trial in preterm infants comparing prophylactic with selective Less Invasive Surfactant Administration” (pro.LISA) - pro.LISA_01_21
niversitaetsklinikum Schleswig-Holstein AöR0 sites698 target enrollmentStarted: July 17, 2024Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- niversitaetsklinikum Schleswig-Holstein AöR
- Enrollment
- 698
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 0 to 17 (—)
- Sex
- All
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
Investigators
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