NCT05960929 InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
| NCT ID | NCT05960929 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ONY |
| Condition | Respiratory Distress Syndrome (Neonatal) |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2025-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria include ALL of the following: 1. Written informed consent obtained by parent or legal representative prior to or after birth 2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks 3. Birthweight ≥ 1,000 AND ≤ 3,500 grams 4. Age ≥ 1 hour AND ≤ 6 hours 5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation 6. Require CPAP 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4 8. If subject is \>346/7 weeks' gestation a chest radiograph is required Exclusion Criteria: Exclusion criteria are ANY of the following: 1. Surfactant administration prior to randomization 2. Mechanical ventilation prior to randomization 3. Major congenital anomaly (suspected or confirmed) 4. Abnormality of the airway (suspected or confirmed) 5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) 6. Apgar score \< 3 at 5 minutes of age 7. Umbilical cord gas pH \<7.0 or BD \> 10 8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Contact & Investigator
Scott Guthrie, MD
STUDY CHAIR
Vanderbilt Jackson-Madison, Jackson TN
Frequently Asked Questions
Who can join the NCT05960929 clinical trial?
This trial is open to participants of all sexes, aged 29 Weeks or older, up to 36 Weeks, studying Respiratory Distress Syndrome (Neonatal). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05960929 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT05960929 currently recruiting?
Yes, NCT05960929 is actively recruiting participants. Contact the research team at ccommaroto@onybiotech.com for enrollment information.
Where is the NCT05960929 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, San Diego, United States, Jacksonville, United States and 6 additional locations.
Who is sponsoring the NCT05960929 clinical trial?
NCT05960929 is sponsored by ONY. The principal investigator is Scott Guthrie, MD at Vanderbilt Jackson-Madison, Jackson TN. The trial plans to enroll 220 participants.