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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

NCT05376267 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

  • Cardiac Arrest, Out-Of-Hospital
  • Hypothermia, Induced
  • Hypoxia-Ischemia, Brain

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Kennedy Krieger Institute, Baltimore, MD

    collaborator UNKNOWN

  • University of Michigan

    lead OTHER

Principal Investigators

  • Frank Moler, MD · University of Michigan

  • Alex Topjian, MD · Children's Hospital of Philadelphia

  • William Meurer, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376267 on ClinicalTrials.gov