Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

Paused · Phase 2

Conditions studied: RDS of Prematurity, Surfactant Protein B Deficiency, Chronic Lung Disease

In brief

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Key facts

Study ID

NCT04056741

Run by

ONY

People needed

55

Starts

2025-02-07

Expected to finish

2026-03-12

Last updated by the study team

2023-11-01

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age at the time of enrollment ≥ 24 0/7 weeks
• Weight at the time of enrollment 500- 5000 grams
• Age ≤ 24 hours old
• Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation)
• Require FiO2 ≤ 40%
• Clinical diagnosis of RDS

You may not qualify if…

• Prior surfactant administration
• Prior mechanical ventilation
• Major congenital anomaly
• Abnormality of the airway
• Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
• Apgar score < 5 at 5 minutes of age

Where it is running

• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Sisters of Charity Hospital — Buffalo, New York, United States
• Jackson-Madison County General Hospital — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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