Overview

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Status:
Recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
NorthShore University HealthSystem
Treatments:
Pulmonary Surfactants