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InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

NCT05960929 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

Infasurf Aero™

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

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • ONY

    lead INDUSTRY

Principal Investigators

  • Scott Guthrie, MD · Vanderbilt Jackson-Madison, Jackson TN

  • Dinushan Kaluarachchi, MD · Unity Point Meriter, Madison WI

  • Jim Cummings, MD · Ony Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2026-04-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960929 on ClinicalTrials.gov