NCT04199364

Medium vs Low Oxygen Threshold for the Surfactant Administration

Comparison of Two Fraction Oxygen Inspired (FiO2) Thresholds for the Surfactant Administration in Preterm Infants With Respiratory Disease Syndrome: a Single-center Randomized Phase IV Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Virgilio Paolo Carnielli · Academic / Other
• Sex: All
• Age: 24 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Poractant Alfa 80 mg/mL Intratracheal Suspension	Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-07-01
• Completion: 2025-04-30
• First posted: 2019-12-13
• Last updated: 2021-04-19