Overview
Medium vs Low Oxygen Threshold for the Surfactant Administration
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-04-30
2025-04-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Virgilio Paolo CarnielliTreatments:
Poractant alfa
Pulmonary Surfactants
Criteria
Inclusion Criteria:- gestational age less than 32 weeks;
- diagnosis of respiratory distress (RDS);
- need for ventilatory support;
- written informed consent.
Exclusion Criteria:
- congenital malformations;
- genetic disorders;
- perinatal asphyxia.
- neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.