Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Study ID: STU-2022-0800
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.
The primary objectives of this project are: A. To determine whether increasing durations of cooling are associated with better outcomes. B. To determine, in pediatric comatose survivors of out-of-hospital cardiac arrest (OHCA), the shortest duration of cooling that provides the maximum treatment effect as determined by Vineland Adaptive Behavior Scales – Third Edition (VABS-3) Mortality Composite Score at one year. The secondary objectives of this project are: i. To characterize the effect of duration of cooling on a global function measure, the Pediatric Cerebral Performance Category (PCPC). ii. To characterize the effect on a standardized neurological outcome measure, the Pediatric Resuscitation after Cardiac Arrest (PRCA) score iii. To characterize the overall safety and adverse events associated with duration of cooling iv. To characterize mortality of varying durations of cooling v. To determine if age group, etiology of CA, or initial GCS motor score influence primary outcome vi. To characterize the effect of cooling on family reported quality of life