Early use of surfacen in the respiratory distress syndrome of the newborn. Phase IV
Phase 4
Recruiting
- Conditions
- ewborn Respiratory Distress Syndrome
- Registration Number
- RPCEC00000099
- Lead Sponsor
- ational Center for Animal Plant and Health (CENSA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Newborn of less than 2 hours 2. Gestational age between 26-36 weeks, both inclusive 3. Patients who meet the criteria of early use of SURFACEN 4. Patient's mother (and/or Patient's father) who expressed voluntarily the participation in the study with the signature of the Informed Consent
Exclusion Criteria
1. Major congenital malformations 2. Severe infections 3. Bronchoaspiration of the meconial amniotic liquid 4. Intrapartum asphyxia 5. Pneumothorax or pneumomediastinum before the beginning of the treatment with SURFACEN. 6. Pulmonary hemorrhage before the beginning of the treatment with SURFACE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total time of ventilation: time reported in hours/days, between begin and the end of the ventilation. Measuring time: 28 days.
- Secondary Outcome Measures
Name Time Method Value of PaO2/FiO2. Measuring time: 1 hour and 4 hours after the first dose of SURFACEN Need for prolonged ventilation (Yes / No). Measuring time: 7 days. Complication Type of Ventilation: complication (s) that occurs in the patient (bronchopulmonary dysplasia, air lock, retinopathy of prematurity, respiratory failure, etc) will be collected (n) (s). Measuring time: 28 days.