drugset / Trial / NCT05960929
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calfactant | Protein / enzyme biologic | 6 unknown | Inhaled |