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InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
NCT05960929 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05960929
The ClinicalTrials.gov registry entry for NCT05960929 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ONY, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05960929 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05960929?
The interventions under investigation include: Infasurf Aero™ (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05960929?
This trial is sponsored by ONY, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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