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 tomaintain 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 ornorepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiationof Extracorporeal membrane oxygenation (ECMO)

• Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral PerformanceCategory (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