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

NCT05376267 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Michigan

Phase

Not applicable

Started

2022-08-05

Last updated

2026-09-08

Condition(s) studied

Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, Brain

Investigational drug(s) / intervention(s)

Therapeutic Hypothermia

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.

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.

Eligibility

Sex

ALL

Min age

2 Days

Max age

17 Years

Healthy volunteers

Inclusion criteria: * Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks * Chest compressions for at least 2 minutes * Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA) * Requires continuous mechanical ventilation through endotracheal tube or tracheostomy * Definitive temperature control device initiated * Randomization within 6 hours of Return of Spontaneous Circulation (ROSC) * Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours Exclusion criteria: * Glasgow Coma Motor Score (GCMS) = 6 * LAR does not speak English or Spanish * Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes * Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO) * Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy * Pre-existing terminal illness, unlikely to survive to one year * Cardiac arrest associated with brain, thoracic, or abdominal trauma * Active and refractory severe bleeding prior to randomization * Extensive burns or skin lesions incompatible with surface cooling * Planned early withdrawal of life support before 120 hours * Sickle cell anemia * Pre-existing cryoglobulinemia * Non-fatal drowning in ice covered water * Central nervous system tumor with ongoing chemotherapy * Previous enrollment in P-ICECAP trial * Prisoner * Chronic hypothermia * New post-cardiac arrest diabetes insipidus * Pregnancy

Primary outcome measure(s)

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.

Trial sites (64)

Facility	City	Region	Status
University of Alabama at Birmingham / Children's of Alabama	Birmingham	Alabama	Recruiting
Phoenix Children's Hospital	Phoenix	Arizona	Recruiting
Banner University Medical Center - Tucson	Tucson	Arizona	Completed
Memorial Health - Miller Children's and Women's Hospital of Long Beach	Long Beach	California	Recruiting
Children's Hospital of Los Angeles	Los Angeles	California	Recruiting
University of California Los Angeles (UCLA) Mattel Children's Hospital	Los Angeles	California	Recruiting
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland	Oakland	California	Recruiting
Children's Hospital of Orange County	Orange	California	Recruiting
University of California, Davis	Sacramento	California	Recruiting
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco	San Francisco	California	Recruiting
Stanford	Santa Clara	California	Recruiting
University of Florida (UF) Health Shands Children's Hospital	Gainesville	Florida	Recruiting
University of Miami	Miami	Florida	Recruiting
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	Recruiting
Ann & Robert Lurie Children's Hospital of Chicago	Chicago	Illinois	Recruiting
Comer Children's Hospital, University of Chicago	Chicago	Illinois	Recruiting
Children's Hospital of Illinois	Peoria	Illinois	Recruiting
Riley Children's Health	Indianapolis	Indiana	Recruiting
University of Iowa, Carver College of Medicine	Iowa City	Iowa	Recruiting
University of Maryland Children's Hospital	Baltimore	Maryland	Recruiting
Johns Hopkins Medicine Children's Center	Baltimore	Maryland	Recruiting
MassGeneral Hospital for Children	Boston	Massachusetts	Recruiting
University of Michigan CS Mott Children's Hospital	Ann Arbor	Michigan	Recruiting
Children's Hospital of Michigan	Detroit	Michigan	Recruiting
University of Minnesota Fairview Masonic Children's Hospital	Minneapolis	Minnesota	Withdrawn
Washington University / St. Louis Children's Hospital	St Louis	Missouri	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Recruiting
Albany Medical Center	Albany	New York	Recruiting
University of Buffalo / Oishei Children's Hospital	Buffalo	New York	Recruiting
Cohen Children's Medical Center of NY / Northwell Health	New Hyde Park	New York	Recruiting
Mount Sinai Icahn / Kravis Children's Hospital	New York	New York	Recruiting
University of Rochester Medical Center	Rochester	New York	Recruiting
Montefiore Einstein Hospital Moses Campus	The Bronx	New York	Recruiting
The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting
Children's Hospital Medical Center of Akron	Akron	Ohio	Recruiting
Cincinnati Children's Hospital	Cincinnati	Ohio	Recruiting
Ohio State University / Nationwide Children's Hospital	Columbus	Ohio	Recruiting
Dayton Children's Hospital	Dayton	Ohio	Recruiting
Oregon Health & Science University Doernbecher Children's Hospital	Portland	Oregon	Recruiting
Penn State University / Penn State Children's Hospital	Hershey	Pennsylvania	Recruiting

+ 24 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05376267 on ClinicalTrials.gov ↗ ← All trials in Canada