Status:
RECRUITING
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Lead Sponsor:
Endeavor Health
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE4
Brief Summary
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respirat...
Detailed Description
INTERVENTION Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct laryngoscop...
Eligibility Criteria
Inclusion
- Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30
Exclusion
- Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
- Infants who require emergent intubation will not be enrolled in the interventions.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT06074380
Start Date
January 1 2024
End Date
December 1 2027
Last Update
August 7 2025
Active Locations (1)
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1
Northshore University Healthsystem
Evanston, Illinois, United States, 60201