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NCT05960929 · ClinicalTrials.gov registry record · Phase 3

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

A Phase 3 study of Intubation Complication and Death; Neonatal, sponsored by ONY.

Recruiting
Registry status
Phase 3
Development phase
220
Enrollment target
10
Study locations

NCT05960929 is a Phase 3 study of Intubation Complication and Death; Neonatal that is actively recruiting participants, run by ONY. The registered enrollment target is 220 participants, below the 26,531-participant average among 10 other Intubation Complication trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT05960929, a Phase 3 study of Intubation Complication and Death; Neonatal, is actively recruiting participants, sponsored by ONY.

RECRUITING
Registry status
Phase 3
Development phase
220 participants
Enrollment target
10
Study locations

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.

Interventions

  • COMBINATION_PRODUCT Infasurf Aero™

Study Locations (10)

Arizona

  • St. Josephs Hospital and Medical Center - Phoenix
  • Phoenix Children's - Phoenix

California

  • Sharp Mary Birch Hospital for Women & Newborns - San Diego

Florida

  • University of Florida -Jacksonville - Jacksonville

Hawaii

  • Kapi'olani Medical Center for Women & Children - Honolulu

New Jersey

  • Jersey Shore University Medical Center - Neptune City

New York

  • Sisters of Charity Hospital - Buffalo

Tennessee

  • Western TN- Jackson-Madison County General Hospital - Jackson

Utah

  • Utah Valley Hospital - Provo

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2025-01-01
Est. Completion 2026-04-01
Phase Phase 3

Sponsor

ONY

3 total trials

What the Registry Record Tells You About NCT05960929

The ClinicalTrials.gov registry entry for NCT05960929 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,531-participant average among 10 other Intubation Complication trials with a reported enrollment target (99% lower). The listed sponsor is ONY, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Intubation Complication appearing as the primary indexed condition, and to 1 intervention - of which Infasurf Aero™ is the first listed.

NCT05960929 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05960929 about?

NCT05960929 is a clinical study titled "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 re...

What is the current status of trial NCT05960929?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2025-01-01. Estimated completion is 2026-04-01.

What conditions does trial NCT05960929 study?

This clinical trial studies the following conditions: Intubation Complication, Death; Neonatal, Respiratory Distress Syndrome (Neonatal).

What interventions are being tested in trial NCT05960929?

The interventions under investigation include: Infasurf Aero™ (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05960929?

This trial is sponsored by ONY, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05960929 being conducted?

This trial has 10 study locations across Arizona, California, Florida, Hawaii, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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