Respiratory Distress Syndrome (RDS)
Conditions
Interventions
Minimally Invasive Surfacen Group (Experimental): A 100 mg/kg dose of SURFACEN® will be administered by less-invasive surfactant administration (LISA) in the first 2 hours of life, as to guarantee the
otherwise, it will be administered using an invasive ventilatory support provided by endotracheal tube.
Sponsors
National Center for Animal and Plant Health (CENSA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient less than 2 hours old. 2. Patient born at gestational age between 26 and 36 weeks or both. 3. Patient with effective and spontaneous breathing, ventilated on nasal CPAP (continuous positive airway pressure) by RDS. 4. Patient with early use of SURFACEN®. The early use criteria are a) Patient with gestational age less than 30 weeks, who have not received prenatal lung maturation and have an established RDS of prematurity; or b) Preterm patients regardless of their gestational age, whether or not they have received prenatal lung maturation, who are on nasal CPAP with 6 cm H2O and require a FiO2 = 0.3 to maintain adequate levels of SpO2 (partial oxygen saturation) in the first two hours of life. 5. Patient whose mother and/or father, or legal representative of the mother, expressed written willingness to participate in the study by signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Major congenital malformations. 2. Perinatal asphyxia and neuromuscular diseases. 3. Pneumothorax or pneumomediastinum prior to the initiation of SURFACEN® treatment. 4. Pulmonary hemorrhage prior to the initiation of SURFACEN® treatment. 5. Severe respiratory distress syndrome. 6. Fraction of inspired oxygen (FiO2) requirements = 0.5. 7. Severe respiratory acidosis. 8. Patient with hemodynamic instability. 9. Patient with recurrent apneas. 10. Patient who has required endotracheal intubation in delivery room, when arriving at ICUs or prior to SURFACEN® treatment. 11. Patient receiving treatment with another product under research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Time Mechanical Ventilation (MV) (Time from when the patient begins ventilating until ventilatory support is discontinued, regardless of the ventilatory mode used.). Measurement time: At baseline and, At patient discharge from Neonatal Intensive Care Unit (NICU). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need for prolonged ventilation (Yes: when ventilation continues at 7 days, No: when ventilation is withdrawn at day 7). Measurement time: Day 7th. 2. Need for endotracheal intubation (Yes, No). Measurement time: Within 72 hours after treatment administration. 3. Need for Invasive Mechanical Ventilation (Yes, No). Measurement time: Within 72 hours after treatment administration. 4. Complications associated with Mechanical Ventilation (Complications presented: Bronchopulmonary Dysplasia (BPD), Retinopathy of Prematurity (ROP), Pneumothorax, Intraventricular Hemorrhage (IVH), Patent Ductus Arteriosus (PDA), Periventricular Leukomalacia (PVL), or others). Measurement time: At patient discharge from NICU. 5. Fraction of Inspired Oxygen-FiO2 (It will be obtained automatically through the values indicated in the ventilation equipment). Measurement time: At baseline, one hour and four hours after each SURFACEN® administration. 6. Oxygenation and blood gas parameters (PaO2/FiO2 ratio, pulse saturation, pH, PaCO2 obtained through blood gas and saturation measurement). Measurement time: At baseline, one hour and four hours after each SURFACEN® administration. 7. NICU stay (Time elapsed between admission and discharge from ICUs). Measurement time: At discharge from NICU. 8. Survival at NICUs discharge (alive or deceased. If deceased, date and cause will be collected). Measurement time: At discharge of NICU. 9. Survival at 28 days after birth (alive or deceased. If deceased, date and cause will be collected). Measurement time: Day 28th. 10. Adverse Events-AE (Occurrence of AE (Yes, No); Type of AE (description of AE); Severity of AE (Severe/Serious, Not severe/Not serious). In case of Severe/Serious: (It threatens the patient life, it prolongs hospitalization, it results in the patient death, in a significant or persistent disability, and in a birth defects or congenital anomalies); Intensity of AE (Mild, Moderate, Severe); Duration of AE (Time elapsed between start and end o | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Perez
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed