Neonatal Interventional Nebulized Surfactant for Preterm Infants with RDS (Neo-INSPIRe) - Trial PACTR202307490670785

Timeline & Enrollment

Summary

Respiratory distress syndrome in preterm infants is an important cause of morbidity and mortality. Less invasive methods of surfactant administration, along with the use of continuous positive airway pressure (CPAP), have improved outcomes of preterm infants. Aerosolized surfactant can be given without the need for airway instrumentation and may be employed in areas where these skills are scarce. Recent trials from high-resourced countries utilising aerosolized surfactant have had a low quality of evidence and varying outcomes.This is a South African, multicentre, phase 2, non-blinded, randomized controlled trial. The purpose of this study is to determine whether aerosolized surfactant (AeroFactTM, SF-RI 1 surfactant for inhalation, delivered by a dedicated delivery system) can improve the course of infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) by reducing the need for intratracheal bolus surfactant instillation in the first 72 hours of age. Eligible participants are inborn preterm infants between 900 – 1999 g and 27 – 34 weeks gestation with a persistent FiO2 of 0.25 – 0.35 on nCPAP between 2 – 24 hours of age. Infants randomized to the Intervention group will receive up to 2 doses of aerosolized surfactant while on nCPAP. Infants randomized to the Control group will continue on nCPAP alone and will not receive aerosolized surfactant as an intervention. Infants in both the Intervention and Control groups with a persistent FiO2 > 0.40 sustained for at least 15 minutes will be regarded as meeting failure criteria and will be eligible to receive intratracheal bolus surfactant instillation.

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