Newborn Respiratory Distress Syndrome
Conditions
Interventions
Surfacen: A dose of 100 mg/kg by endotracheal instillation. The administration will ocurr in the first two hours of life, after the patient is stable hemodynamically and metabolically. If required, m
Sponsors
National Center for Animal Plant and Health (CENSA)
Not apply
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 SURFACEN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total time of ventilation: time reported in hours/days, between begin and the end of the ventilation. Measuring time: 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Pérez
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed