Trials / Recruiting
RecruitingNCT05376267
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 2 Days – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Therapeutic Hypothermia | Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours. |
Timeline
- Start date
- 2022-08-05
- Primary completion
- 2028-03-31
- Completion
- 2028-03-31
- First posted
- 2022-05-17
- Last updated
- 2026-04-14
Locations
60 sites across 5 countries: United States, Australia, Canada, New Zealand, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05376267. Inclusion in this directory is not an endorsement.