Study of InfasurfAero Nebulizer Treatment Versus Sham in Preterm Newborns with Respiratory Distress Syndrome A Single-Dose, Double-Blind, Randomized, Sham-Controlled Phase 3 Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Infasurf4 administered through the InfasurfAero22, a new oral airway delivery device designed to provide Infasurf in a simpler way without needing a breathing tube or interrupting nasal respiratory support. This clinical trial focuses on preterm newborns with respiratory distress syndrome RDS who are stable and breathing on non-invasive nasal respiratory support. The study is a single-dose, double-blind, randomized, sham-controlled trial conducted at multiple sites. Participants will be randomly assigned to receive either a single dose of Calfactant at 6 mlkg via the InfasurfAero22 nebulizer or low flow respiratory air alone through the same device. The dose is given by inhalation through a pacifier interface until completion. The study compares the intervention with a sham control to assess prevention of CPAP failure and overall safety. During the study, newborns will be monitored for CPAP failure or death within the first week of age as the primary outcome. Secondary outcomes include chronic lung disease, incidence and duration of mechanical ventilation, intubation, invasive surfactant therapy, non-invasive support duration, and supplemental oxygen use up to 36 weeks post menstrual age. The total participation period and detailed follow-up assessments are designed to evaluate both safety and effectiveness thoroughly.

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS