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NCT05376267 · ClinicalTrials.gov registry record · NA
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
A NA study of Cardiac Arrest, Out-Of-Hospital and Hypoxia-Ischemia, Brain, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 900
- Enrollment target
- 20
- Study locations
NCT05376267: Recruiting NA study of Cardiac Arrest, Out-Of-Hospital and Hypoxia-Ischemia, Brain, sponsored by University of Michigan.
NCT05376267 is a NA study of Cardiac Arrest, Out-Of-Hospital and Hypoxia-Ischemia, Brain that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 900 participants, below the 1,446-participant average among 5 other Cardiac Arrest, Out-Of-Hospital trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05376267, a NA study of Cardiac Arrest, Out-Of-Hospital and Hypoxia-Ischemia, Brain, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 900 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
Conditions Studied
Interventions
- DEVICE Therapeutic Hypothermia
Study Locations (20)
California
- Memorial Health - Miller Children's and Women's Hospital of Long Beach - Long Beach
- Children's Hospital of Los Angeles - Los Angeles
- University of California Los Angeles (UCLA) Mattel Children's Hospital - Los Angeles
- University of California - Oakland / UCSF Benoiff Children's Hospital Oakland - Oakland
- Children's Hospital of Orange County - Orange
- University of California, Davis - Sacramento
- University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco - San Francisco
- Stanford - Santa Clara
Illinois
- Ann & Robert Lurie Children's Hospital of Chicago - Chicago
- Comer Children's Hospital, University of Chicago - Chicago
- Children's Hospital of Illinois - Peoria
Arizona
- Phoenix Children's Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Florida
- University of Florida (UF) Health Shands Children's Hospital - Gainesville
- University of Miami - Miami
Maryland
- University of Maryland Children's Hospital - Baltimore
- Johns Hopkins Medicine Children's Center - Baltimore
Alabama
- University of Alabama at Birmingham / Children's of Alabama - Birmingham
Indiana
- Riley Children's Health - Indianapolis
Iowa
- University of Iowa, Carver College of Medicine - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2022-08-05 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What NCT05376267 shows while recruiting
NCT05376267 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, below the 1,446-participant average among 5 other Cardiac Arrest, Out-Of-Hospital trials with a reported enrollment target (38% lower).
The record links to 3 conditions, with Cardiac Arrest, Out-Of-Hospital appearing as the primary indexed condition, and to 1 intervention - of which Therapeutic Hypothermia is the first listed.
NCT05376267 names 20 study sites across 8 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT05376267 about?
NCT05376267 is a clinical study titled "Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)". 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 att...
What is the current status of trial NCT05376267?
This trial is currently recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2022-08-05. Estimated completion is 2028-03-31.
What conditions does trial NCT05376267 study?
This clinical trial studies the following conditions: Cardiac Arrest, Out-Of-Hospital, Hypoxia-Ischemia, Brain, Hypothermia, Induced.
What interventions are being tested in trial NCT05376267?
The interventions under investigation include: Therapeutic Hypothermia (DEVICE).
Who is sponsoring clinical trial NCT05376267?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05376267 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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