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Non Inferiority Trial Investigating Surfactants Administered Via MIST

Study acronym: Niftisurf
StatusRecruiting
PhasePhase 4
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contact updatedv4
  2. Study description shortened, about 201 wordsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Oct 30, 2025 to Dec 30, 2025
    • Start date changed from estimate of Nov 1, 2023 to Jan 1, 2024
    • Site details revised
    • Study description expanded, about 1 word
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06074380
Lead Sponsor Endeavor Health
Conditions
(from sponsor)		 Respiratory Distress Syndrome
Related terms Respiratory Distress Syndrome
Enrollment 262 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov