SURFACEN ARDS. Pediatrics. Phase III
Phase 3
- Conditions
- Respiratory distress syndrome in pediatric patients
- Registration Number
- RPCEC00000163
- Lead Sponsor
- ational Center for Animal and Plant Health (CENSA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
1. Presence of ARDS within 72 hours of diagnosis, 2. PEEP> 5 cm H2O. 3. Patients whose parents / guardians give their written consent to participate in the study. 4. Aged 28 days old and 18 years inclusive.
Exclusion Criteria
1. Onco-hematological diseases. 2. Chronic heart disease (ventricular septal defect, atrial septal defect, patent ductus arteriosus, pulmonary stenosis, coarctation of the aorta, aortic stenosis, tetralogy of Fallot, transposition of great arteries, tricuspid atresia and truncus). 3. Hypersensitivity to the surface or other component of the formulation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Condition (Alive, Dead). Measurement time: 28 days
- Secondary Outcome Measures
Name Time Method