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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: Recruiting Phase 3 study of Intubation Complication and Death; Neonatal, sponsored by ONY.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) \>2.5 on two consecutive assessments at least 30 minutes apart, or an RSS \> 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 3 |
What NCT05960929 shows while recruiting
NCT05960929 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 26,531-participant average among 10 other Intubation Complication trials with a reported enrollment target (99% lower).
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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Intubation Complication
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05960929's enrollment target sits among peer trials
220 8th of 10 higher than 3 of 10 other Intubation Complication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intubation Complication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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