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Effect of cooling duration on recovery in children after cardiac arrest

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

Not applicable Interventional University of Michigan · NCT05376267

This study is testing if cooling children who are in a coma after a cardiac arrest for longer periods can help them recover better.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment900 (estimated)
Ages2 Days to 17 Years
SexAll
SponsorUniversity of Michigan Academic / other
Drugs / interventionschemotherapy
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT05376267 on ClinicalTrials.gov

What this trial studies

This multicenter trial aims to determine the efficacy of therapeutic hypothermia and the optimal duration of cooling for neuroprotection in pediatric patients who are comatose after experiencing out-of-hospital cardiac arrest. The study hypothesizes that longer cooling durations may enhance the likelihood of achieving good neurobehavioral recovery in these children. Participants will be randomized within six hours of return of spontaneous circulation, and the trial will utilize a Bayesian adaptive design to evaluate outcomes. The focus is on improving recovery rates among pediatric survivors of cardiac arrest.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 days to under 18 years who are comatose after out-of-hospital cardiac arrest and require mechanical ventilation.

Not a fit: Patients with severe pre-existing neurodevelopmental deficits or those who have experienced prolonged CPR may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve recovery outcomes for children who have suffered cardiac arrest.

How similar studies have performed: Other studies have shown promising results with therapeutic hypothermia in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, BrainBayesian Adaptive Clinical TrialHypothermia, therapeuticComaPediatric
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.