drugset / Trial / NCT05960929

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

NCT05960929

Phase 3 Recruiting 220 enrolled ONY Avania · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-01-01
Primary completion
2026-01-01
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Calfactant Protein / enzyme biologic 6 unknown Inhaled