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NCT04181255 · ClinicalTrials.gov registry record · Phase 1
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
A Phase 1 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04181255: Clinical Trial Phase 1 study, sponsored by University of Michigan.
NCT04181255 is a Phase 1 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04181255, a Phase 1 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.
Primary Outcome
This will be the number of days from intubation to the extubation date.
Interventions
- DRUG Sham
- DRUG Curosurf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2020-06-12 |
| Phase | Phase 1 |
Why NCT04181255 stopped before completion
NCT04181255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT04181255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04181255 about?
NCT04181255 is a clinical study titled "Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy". This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there ...
What is the current status of trial NCT04181255?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2020-02-25. Estimated completion is 2020-06-12.
What interventions are being tested in trial NCT04181255?
The interventions under investigation include: Sham (DRUG), Curosurf (DRUG).
Who is sponsoring clinical trial NCT04181255?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04181255's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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