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P-ICECAP Study: Cooling for Children After Cardiac Arrest

This study, called P-ICECAP, is looking at how long children should receive therapeutic hypothermia (cooling the body) after an out-of-hospital cardiac arrest (when the heart stops beating outside of a hospital). Researchers want to find out if cooling helps protect the brain and what the best cooling duration is for children aged 2 days to 17 years who are in a coma after their heart stopped. The study plans to enroll 900 participants. Success in this study means seeing improved neurobehavioral recovery (how well the brain functions) 12 months after the heart started beating again. The current recruitment status is unclear.

Study design
This is a multicenter interventional study planning to enroll 900 participants. It is testing different durations of therapeutic hypothermia.
What's involved
Participants will receive therapeutic hypothermia for a specific number of hours, followed by controlled rewarming. They will be assessed 12 months after their heart started beating again.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their heart started beating again.

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NCT05376267

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

Recruiting
NAAges 2–17InterventionalTreatment
University of Michigan
~900 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Therapeutic Hypothermia

At a glance

Recruiting sites
59 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
Measured over 12 months after out-of-hospital cardiac arrest

Conditions

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

Explore related trials

Cardiac ArrestComaHypoxic Ischemic Encephalopathy

Where it's being run

62 sites across 31 states
California8
New York6
Ohio4
Texas4
Florida3
Illinois3
Pennsylvania3
Queensland3

Study leadership

  • Frank Moler, MD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Alex Topjian, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
  • William Meurer, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Frank Moler, MD
[email protected]
734-764-5302
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation12 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.