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

Not Applicable

Recruiting

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

• Registration Number: NCT05376267
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-08-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation	12 months after out-of-hospital cardiac arrest	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.

Secondary Outcome Measures

Name	Time	Method
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months	12 months after cardiac arrest	The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline	Baseline and 12 months after cardiac arrest	The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.
Survival at 12 months	12 months after cardiac arrest

Trial Locations

Locations (54)

University of Alabama at Birmingham / Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Banner University Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Memorial Health - Miller Children's and Women's Hospital of Long Beach; 🇺🇸 Long Beach, California, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles (UCLA) Mattel Children's Hospital; 🇺🇸 Los Angeles, California, United States

University of California - Oakland / UCSF Benoiff Children's Hospital Oakland; 🇺🇸 Oakland, California, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco; 🇺🇸 San Francisco, California, United States

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