InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal

In brief

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.

Key facts

Study ID

NCT05960929

Run by

ONY

People needed

220

Starts

2025-01-01

Expected to finish

2026-04-01

Last updated by the study team

2025-03-30

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria include ALL of the following:
• Written informed consent obtained by parent or legal representative prior to or after birth
• Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
• Birthweight ≥ 1,000 AND ≤ 3,500 grams
• Age ≥ 1 hour AND ≤ 6 hours
• 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
• Require CPAP
• Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
• If subject is >346/7 weeks' gestation a chest radiograph is required

You may not qualify if…

• Exclusion criteria are ANY of the following:
• Surfactant administration prior to randomization
• Mechanical ventilation prior to randomization
• Major congenital anomaly (suspected or confirmed)
• Abnormality of the airway (suspected or confirmed)
• 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)
• Apgar score < 3 at 5 minutes of age
• Umbilical cord gas pH <7.0 or BD > 10
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Where it is running

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

Full record on ClinicalTrials.gov

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