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Prophylactic Minimally Invasive Surfactant Evaluation

Study acronym: PreProMISe
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 31, 2025 to Dec 31, 2025
    • Start date changed from estimate of Nov 1, 2023 to Jan 1, 2024
    • Site details revised
    v3
  3. Start date: Sep 1, 2023 to Nov 1, 2023
    • Primary completion date: Jul 31, 2025 to Oct 31, 2025
    • Eligibility criteria expanded, about 4 words
    • Collaborators expanded, about 3 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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?
Trial Details
NCT Number NCT06007547
Lead Sponsor Endeavor Health
Collaborators: Chiesi USA, Inc.
Conditions
(from sponsor)		 Respiratory Distress Syndrome, Newborn, Premature Birth
Related terms Premature Birth, Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov