Effect of cooling duration on recovery in children after cardiac arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham / Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Memorial Health - Miller Children's and Women's Hospital of Long Beach
  Long Beach, California, United States Recruiting
• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• University of California Los Angeles (UCLA) Mattel Children's Hospital
  Los Angeles, California, United States Recruiting
• University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
  Oakland, California, United States Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Frank Moler, MD — University of Michigan
• Study coordinator: Frank Moler, MD
• Email: fmoler@umich.edu
• Phone: 734-764-5302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.