Clinical Trial

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Study acronym: Niftisurf
Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated August 7, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-09-27; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2024-02-19
Trial Details
NCT Number NCT06074380
Lead Sponsor Endeavor Health
Conditions Respiratory Distress Syndrome
Enrollment 262 participants
Start Date 2024-01-01
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-07