At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With Respiratory Distress Syndrome During Non Invasive Ventilation: a Randomized Controlled Trial
In Brief
A clinical study evaluating Poractant alfa, 200 mg/kg, Ventilator for High-frequency Oscillatory Ventilation (HFOV), and 1 other intervention for Respiratory Distress Syndrome and Hyaline Membrane Disease. Completed, enrolled 206 participants across 33 sites.
Detailed Summary
The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.
Study Details
Timeline
Interventions
Endotracheal Surfactant administration
This device will be used to perform an HFOV recruitment maneuver before surfactant administration
After surfactant administration, the babies will be extubated within 30 minutes and will receive nCPAP (6-8 cm H2O)