Gender
All
Age Group
2 Days to 17 Years
Accepting Healthy Volunteers
No
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