Clinical Trial

Prophylactic Minimally Invasive Surfactant Evaluation

Study acronym: PreProMISe
Recruiting Phase 4
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Record status
This record was last updated August 7, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-22; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2024-02-19
Trial Details
NCT Number NCT06007547
Lead Sponsor Endeavor Health
Collaborators: Chiesi USA, Inc.
Conditions Respiratory Distress Syndrome, Newborn, Premature Birth
Enrollment 200 participants
Start Date 2024-01-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-07