Status:
SUSPENDED
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
Lead Sponsor:
ONY
Conditions:
RDS of Prematurity
Surfactant Protein B Deficiency
Eligibility:
All Genders
24+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 12 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04056741
Start Date
February 7 2025
End Date
March 12 2026
Last Update
November 1 2023
Active Locations (4)
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1
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
2
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
3
Sisters of Charity Hospital
Buffalo, New York, United States, 14214
4
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301