Current Environment:

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.

Conditions

Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain

Recruitment Status

Recruiting

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Device

Therapeutic Hypothermia

Phase

Not Applicable

Gender

All

Min Age

2 Days

Max Age

17 Years

Download Date

May 23, 2024

Principal Investigator

Sarah Murphy, MD 

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Sarah Murphy, MD
samurphy@mgh.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) NCT05376267 Sarah Murphy, MD samurphy@mgh.harvard.edu