Tidlig selektiv behandling med Curosurf.Behandling af RDS efter bestemmelse af lamellar body counts på ventrikelaspirat sammenholdt med behandling ved a/APO2 <0,36En randomiseret kontrolleret multicenterundersøgelse af børn efter 24-29 uger - Tidlig selektiv behandling med Curosurf
Phase 1
- Conditions
- Respiratory Distress Syndrome (RDS) in infants 24-29 weeks`gestation
- Registration Number
- EUCTR2006-001563-37-DK
- Lead Sponsor
- Department of Pediatrics Holbaek Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
1. GA 24 + 0 to 29 + 9 wk
2. Early nasal CPAP
3. Gastric aspirate not later than 45 min after birth
4. Informed consent (written and orally) before birth or lates 1 h after birth
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Exclusion Criteria
1. Prolonged rupture of the membranes > 3 wk
2. Therapeutic infusions in the amniotic cave
3. Lethal malformations
4. Intubation in the delivery room before randomisation
5. Meconium or pus contamination of the gastric aspirate
6. The neonatal ward too busy with other patients
7. No gastric aspirate
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