NCT05960929

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: ONY · Industry
• Sex: All
• Age: 29 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™. The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero. Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

Conditions

• Respiratory Distress Syndrome (Neonatal)
• Intubation Complication
• Death; Neonatal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Infasurf Aero™	A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2023-07-27
• Last updated: 2025-03-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study