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Purpose

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

Eligibility

Eligible Ages
Between 2 Days and 17 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Bayesian Adaptive Design
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
The outcomes assessors will be blinded to the treatment assignment of the participant.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cooling 0 hours 		Participants will be kept at a normal temperature for the whole 5 days.
  • Device: Therapeutic 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.
Experimental
Cooling 12 hours 		The participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 18 hours 		The participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 24 hours 		The participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 36 hours 		The participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 48 hours 		The participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 60 hours 		The participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 72 hours 		The participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 84 hours 		The participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.
Experimental
Cooling 96 hours 		The participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
  • Device: Therapeutic 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.

Recruiting Locations

University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama 35233
Contact:
Michele Kong, MD
205-638-9387
mkong@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Frank Moler, MD
734-764-5302
fmoler@umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.