Status: Recruiting
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Participants needed: 220
Trial details
Phase: Phase 3Age: 29-36Biological sex: AllType: InterventionalSponsor: ONYUpdated: Mar 30, 2025Locations: 10
Eligibility criteria
Written informed consent obtained by parent or legal representative prior to or... [+7]
Surfactant administration prior to randomization [+7]