Actively Recruiting
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Led by Endeavor Health · Updated on 2025-08-07
262
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age
- Clinical diagnosis of respiratory distress syndrome confirmed by chest x-ray
- Receiving nasal continuous positive airway pressure (NCPAP) with FiO2 0.30
You will not qualify if you...
- Presence of a congenital anomaly
- Alternative cause for respiratory distress
- Requirement for emergent intubation prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northshore University Healthsystem
Evanston, Illinois, United States, 60201
Actively Recruiting
Research Team
M
Matthew Derrick
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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