Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Summary
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Eligibility
- Age range
- 0–17 years
- Sex
- All
- 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 Com…
Interventions
- DeviceTherapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
Locations (60)
- University of Alabama at Birmingham / Children's of AlabamaBirmingham, Alabama
- Phoenix Children's HospitalPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- Memorial Health - Miller Children's and Women's Hospital of Long BeachLong Beach, California
- Children's Hospital of Los AngelesLos Angeles, California
- University of California Los Angeles (UCLA) Mattel Children's HospitalLos Angeles, California