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RECRUITING
NCT06074380
PHASE4

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Sponsor: Endeavor Health

View on ClinicalTrials.gov

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

Interventions

DRUG

MIST surfactant

Surfactant will be given via MIST while neonate is on CPAP

Locations (1)

Northshore University Healthsystem

Evanston, Illinois, United States