Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Respiratory Distress Syndrome
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Participants will be masked.Primary Purpose: Treatment

Participation Requirements

Age
Younger than 2432 years
Gender
Both males and females

Description

Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for t...

Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear. In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.

Tracking Information

NCT #
NCT04199364
Collaborators
Not Provided
Investigators
Not Provided