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Non Inferiority Trial Investigating Surfactants Administered Via MIST
Sponsor: Endeavor Health
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 respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.
Key Details
Gender
All
Age Range
Any - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2024-01-01
Completion Date
2027-12-01
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
MIST surfactant
Surfactant will be given via MIST while neonate is on CPAP
Locations (1)
Northshore University Healthsystem
Evanston, Illinois, United States