InfasurfAero™ for treating respiratory distress in preterm newborns
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
This study is testing a new device that delivers a treatment for breathing problems in preterm newborns to see if it helps them breathe better without needing a breathing tube.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 29 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Ony Industry-sponsored |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT05960929 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Infasurf® delivered through the InfasurfAero™, a novel device designed for non-invasive administration without the need for intubation. The study involves a double-blind, randomized, sham-controlled design, where preterm newborns with respiratory distress syndrome (RDS) will receive either Infasurf or a sham treatment. The primary objectives are to assess the prevention of CPAP failure and the safety of the treatment. Participants will be recruited from multiple sites, with a focus on those who are stable on non-invasive respiratory support.
Who should consider this trial
Good fit: Ideal candidates are preterm newborns aged between 1 to 6 hours, with a gestational age of 29 to 35 weeks and diagnosed with surfactant-deficient RDS.
Not a fit: Patients who have received surfactant treatment or mechanical ventilation prior to randomization will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve respiratory support for preterm newborns with RDS, reducing the need for invasive procedures.
How similar studies have performed: Other studies have shown promise with similar non-invasive approaches for treating RDS, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 9 other locations
- St. Josephs Hospital and Medical Center — Phoenix, Arizona, United States (Recruiting)
- Phoenix Children's — Phoenix, Arizona, United States (Recruiting)
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (Recruiting)
- University of Florida -Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Kapi'olani Medical Center for Women & Children — Honolulu, Hawaii, United States (Recruiting)
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States (Recruiting)
- Sisters of Charity Hospital — Buffalo, New York, United States (Recruiting)
- Western TN- Jackson-Madison County General Hospital — Jackson, Tennessee, United States (Recruiting)
- Utah Valley Hospital — Provo, Utah, United States (Recruiting)
- Unity Point Meriter — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Corey Commaroto, RRT
- Email: ccommaroto@onybiotech.com
- Phone: 7163614659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.