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

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