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Clinical Trials in the USA / NCT05960929
Recruiting Phase 3

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

NCT05960929 · tracked via the Priya Life Science USA tracker
Sponsor
ONY
Phase
Phase 3
Started
2025-01-01
Last updated
2025-03-30

Condition(s) studied

Respiratory Distress Syndrome (Neonatal)Intubation ComplicationDeath; Neonatal

Investigational drug(s) / intervention(s)

Infasurf Aero™

Infasurf Aero™: A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

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.

Eligibility

Sex
ALL
Min age
29 Weeks
Max age
36 Weeks
Healthy volunteers
No
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

Primary outcome measure(s)

  • CPAP failure and or death — Within 1st week of age
    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 (pCO2 \> 65 with a pH \< 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.

Trial sites (10)

FacilityCityRegionStatus
St. Josephs Hospital and Medical Center Phoenix Arizona Recruiting
Phoenix Children's Phoenix Arizona Recruiting
Sharp Mary Birch Hospital for Women & Newborns San Diego California Recruiting
University of Florida -Jacksonville Jacksonville Florida Recruiting
Kapi'olani Medical Center for Women & Children Honolulu Hawaii Recruiting
Jersey Shore University Medical Center Neptune City New Jersey Recruiting
Sisters of Charity Hospital Buffalo New York Recruiting
Western TN- Jackson-Madison County General Hospital Jackson Tennessee Recruiting
Utah Valley Hospital Provo Utah Recruiting
Unity Point Meriter Madison Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05960929 on ClinicalTrials.gov ↗ ← All trials in the USA