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

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)

Facility	City	Region	Status
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