Non Inferiority Trial Investigating Surfactants Administered Via MIST for Respiratory Distress Syndrome in Preterm Infants

What this Trial Is About

This research investigates treatment options for preterm infants aged 28 to 35 weeks with respiratory distress syndrome who are less than 48 hours old. The trial compares two types of surfactants, calfactant (Infasurf) and poractant alfa (Curosurf), administered using a minimally invasive surfactant therapy (MIST) catheter while the infants are on nasal continuous positive airway pressure (NCPAP) with an oxygen level of at least 30%. The goal is to determine if one surfactant is not inferior to the other in reducing the need for intubation. Infants on NCPAP reaching 30% oxygen are randomly assigned to receive either calfactant at 3 ml/kg or poractant alfa at 2.5 ml/kg via a MIST catheter under direct laryngoscopy. A second dose may be given between 6 and 48 hours after the first if oxygen levels remain at or above 30%. No additional surfactant is given during the first week unless intubation criteria are met, at which point further surfactant can be administered. The clinical team manages other respiratory support, including adjusting CPAP and using nasal intermittent positive pressure ventilation if needed. Participants are closely monitored for outcomes including the number of infants needing endotracheal intubation within 7 days, duration of positive pressure support, and oxygen supplementation up to 36 weeks corrected gestational age. The study includes assessments of respiratory status and adherence to intubation criteria. Parental consent is obtained prior to randomization, and the trial is conducted across multiple centers with double-blind treatment allocation.

Non Inferiority Trial Investigating Surfactants Administered Via MIST