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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Therapeutic Hypothermia
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric

Eligibility Criteria

2 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham / Children's of AlabamaRecruiting
  • Phoenix Children's HospitalRecruiting
  • Banner University Medical Center - TucsonRecruiting
  • Memorial Health - Miller Children's and Women's Hospital of Long BeachRecruiting
  • University of California Los Angeles (UCLA) Mattel Children's HospitalRecruiting
  • University of California - Oakland / UCSF Benoiff Children's Hospital OaklandRecruiting
  • Children's Hospital of Orange CountyRecruiting
  • University of California, DavisRecruiting
  • University of California - San Francisco (UCSF) Benioff Children's Hospital San FranciscoRecruiting
  • StanfordRecruiting
  • University of Florida (UF) Health Shands Children's HospitalRecruiting
  • University of MiamiRecruiting
  • Ann & Robert Lurie Children's Hospital of ChicagoRecruiting
  • Children's Hospital of IllinoisRecruiting
  • Riley Children's HealthRecruiting
  • University of Iowa, Carver College of MedicineRecruiting
  • University of Maryland Children's HospitalRecruiting
  • Johns Hopkins Medicine Children's CenterRecruiting
  • MassGeneral Hospital for ChildrenRecruiting
  • University of Michigan CS Mott Children's HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • University of Minnesota Fairview Masonic Children's Hospital
  • Washington University / St. Louis Children's HospitalRecruiting
  • University of Buffalo / Oishei Children's HospitalRecruiting
  • Cohen Children's Medical Center of NY / Northwell HealthRecruiting
  • Mount Sinai Icahn / Kravis Children's HospitalRecruiting
  • University of Rochester Medical CenterRecruiting
  • The University of North Carolina at Chapel HillRecruiting
  • Children's Hospital Medical Center of AkronRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Ohio State University / Nationwide Children's HospitalRecruiting
  • Oregon Health & Science University Doernbecher Children's HospitalRecruiting
  • Penn State University / Penn State Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Children's Hospital of Pittsburgh (UPMC)Recruiting
  • University of Tennesses Health Center / Le Bonheur Children'sRecruiting
  • Children's Medical Center of DallasRecruiting
  • Texas Children's Hospital, Baylor
  • The University of Texas Health Science Center at San AntonioRecruiting
  • Primary Children's Hospital, University of Utah School of MedicineRecruiting
  • American Family Children's HospitalRecruiting
  • Children's WisconsinRecruiting
  • The Hospital for Sick Children
  • Birmingham Children's Hospital, United Kingdom

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cooling 0 hours

Cooling 12 hours

Cooling 18 hours

Cooling 24 hours

Cooling 36 hours

Cooling 48 hours

Cooling 60 hours

Cooling 72 hours

Cooling 84 hours

Cooling 96 hours

Arm Description

Participants will be kept at a normal temperature for the whole 5 days.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.

Secondary Outcome Measures

Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.
Survival at 12 months

Full Information

First Posted
May 11, 2022
Last Updated
September 12, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kennedy Krieger Institute, Baltimore, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05376267
Brief Title
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Official Title
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
March 31, 2028 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kennedy Krieger Institute, Baltimore, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
Keywords
Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Bayesian Adaptive Design
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will be blinded to the treatment assignment of the participant.
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cooling 0 hours
Arm Type
Experimental
Arm Description
Participants will be kept at a normal temperature for the whole 5 days.
Arm Title
Cooling 12 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 18 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 24 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 36 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 48 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 60 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 72 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 84 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooling 96 hours
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Therapeutic Hypothermia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
Description
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
Time Frame
12 months after out-of-hospital cardiac arrest
Secondary Outcome Measure Information:
Title
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
Description
The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.
Time Frame
Baseline and 12 months after cardiac arrest
Title
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
Description
The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.
Time Frame
12 months after cardiac arrest
Title
Survival at 12 months
Time Frame
12 months after cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Moler, MD
Phone
734-764-5302
Email
fmoler@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Moni Weber
Phone
734-232-4803
Email
monij@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Moler, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Topjian, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Meurer, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham / Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Kong, MD
Phone
205-638-9387
Email
mkong@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Michele Kong, MD
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. Anthony Willyerd, MD
Phone
602-471-5064
Email
fwillyerd@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
F. Anthony Willyerd, MD
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Gaspers, MD
First Name & Middle Initial & Last Name & Degree
Mary Gaspers, MD
Facility Name
Memorial Health - Miller Children's and Women's Hospital of Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806-1701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Babbitt, MD
Phone
562-933-8743
Email
CBabbitt@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Christopher Babbitt, MD
Facility Name
University of California Los Angeles (UCLA) Mattel Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Sapru, MD
Email
asapru@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Anil Sapru, MD
Facility Name
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Cvijanovich, MD
Phone
510-428-3302
First Name & Middle Initial & Last Name & Degree
Natalie Cvijanovich, MD
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868-4203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Schwarz, MD
Phone
714-509-8620
Email
aschwarz@choc.org
First Name & Middle Initial & Last Name & Degree
Adam Schwarz, MD
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Siefkes, MD
Phone
916-734-7620
Email
hsiefkes@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Heather Siefkes, MD
Facility Name
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick McQuillen, MD
Email
patrick.mcquillen@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Patrick McQuillen, MD
Facility Name
Stanford
City
Santa Clara
State/Province
California
ZIP/Postal Code
95050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Cornell, MD
Email
tcornell@stanford.edu
First Name & Middle Initial & Last Name & Degree
Tim Cornell, MD
Facility Name
University of Florida (UF) Health Shands Children's Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Avery, MD, JD, MBA
Phone
352-265-0462
Email
avery4@ufl.edu
First Name & Middle Initial & Last Name & Degree
K. Leslie Avery, MD, JD, MBA
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Munoz Pareja, MD
Email
jcm457@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Munoz Pareja, MD
Facility Name
Ann & Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Smith, MD
Phone
312-227-4800
Email
CMSmith@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Craig Smith, MD
Facility Name
Children's Hospital of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Tripathi, MD
Phone
309-624-0719
Email
sandeept@uic.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Tripathi, MD
Facility Name
Riley Children's Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Yuknis, MD
Phone
317-944-3345
Email
myuknis@iupui.edu
First Name & Middle Initial & Last Name & Degree
Matthew Yuknis, MD
Facility Name
University of Iowa, Carver College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Wellnitz, MD
Email
kari-wellnitz@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Kari Wellnitz, MD
Facility Name
University of Maryland Children's Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddhartha Dante, MD
Email
abhutta@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Siddhartha Dante, MD
Facility Name
Johns Hopkins Medicine Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin O'Brien, MD, MPH
Phone
720-635-1730
Email
Cobrie19@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Caitlin O'Brien, MD, MPH
Facility Name
MassGeneral Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah MD Murphy, MD
Phone
617-724-4380
Email
samurphy@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Sarah Murphy, MD
Facility Name
University of Michigan CS Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Barbaro, MD
Email
barbaror@umich.edu
First Name & Middle Initial & Last Name & Degree
Ryan Barbaro, MD
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Meert, MD
Phone
313-745-5870
Email
meert1kl@cmich.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Meert, MD
Facility Name
University of Minnesota Fairview Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University / St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Friess, MD
Email
friess@wustl.edu
First Name & Middle Initial & Last Name & Degree
Stuart Friess, MD
Facility Name
University of Buffalo / Oishei Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Breuer, MD
Email
ryanbrue@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Ryan Breuer, MD
Facility Name
Cohen Children's Medical Center of NY / Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Sweberg, MD
Phone
718-470-3668
Email
tsweberg@northwell.edu
First Name & Middle Initial & Last Name & Degree
Todd Sweberg, MD
Facility Name
Mount Sinai Icahn / Kravis Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shubhi Kaushik, MD
First Name & Middle Initial & Last Name & Degree
Shubhi Kaushik, MD
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-8667
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jake Deines, MD
Phone
585-273-5269
Email
Jake_deines@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Jake Deines, MD
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benny Joyner, MD, MPH
Phone
919-966-7495
Email
benny@unc.edu
First Name & Middle Initial & Last Name & Degree
Benny Joyner, MD, MPH
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Nofziger, MD
Phone
330-543-8639
Email
mofziger@akronchildrens.org
First Name & Middle Initial & Last Name & Degree
Chris Page-Goertz, MD
Phone
330-543-8639
Email
cpage-goertz@akronchildrens.org
First Name & Middle Initial & Last Name & Degree
Ryan Nofziger, MD
First Name & Middle Initial & Last Name & Degree
Chris Page-Goertz, MD
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranjit Chima, MD
Email
ranjit.chima@cchmc.org
First Name & Middle Initial & Last Name & Degree
Ranjit Chima, MD
Facility Name
Ohio State University / Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlina Lovett, MD
Email
marlina.lovett@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Marlina Lovett, MD
Facility Name
Oregon Health & Science University Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamud Daya, MD, MS
Phone
503-494-7248
Email
dayam@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Serena Kelly, MS
Phone
503-789-4580
Email
phromsiv@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Serena Kelly, MS
Facility Name
Penn State University / Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Thomas, MD
Email
nthomas@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Neal Thomas, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Kirschen, MD
Email
kirschenm@chop.edu
First Name & Middle Initial & Last Name & Degree
Matthew Kirschen, MD
Facility Name
Children's Hospital of Pittsburgh (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ericka Fink, MD
Email
finkel@ccm.upmc.edu
First Name & Middle Initial & Last Name & Degree
Ericka Fink, MD
Facility Name
University of Tennesses Health Center / Le Bonheur Children's
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Schaller, DO
Phone
901-287-5925
Email
aschalle@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Schaller, DO
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Wolovits, MD
Email
joshua.wolovits@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Joshua Wolovits, MD
Facility Name
Texas Children's Hospital, Baylor
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Erklauer, MD
Email
jclee@bcm.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Erklauer, MD
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Wu, MD
Phone
210-567-5816
Email
wut@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Theodore Wu, MD
Facility Name
Primary Children's Hospital, University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Sweney, MD
Email
jill.sweney@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jill Sweney, MD
Facility Name
American Family Children's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Ferrazzano, MD
Phone
608-265-4839
Email
ferrazzano@pediatrics.wisc.edu
First Name & Middle Initial & Last Name & Degree
Peter Ferrazzano, MD
Facility Name
Children's Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binod Balakrishnan, MD
Phone
414-266-3360
Email
bbalakris@mcw.edu
First Name & Middle Initial & Last Name & Degree
Binod Balakrishnan, MD
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Guerguerian, MD, PhD
Phone
416-813-7654
Email
anne-marie.guerguerian@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Anne-Marie Guerguerian, MD, PhD
Facility Name
Birmingham Children's Hospital, United Kingdom
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barney Scholefield, MD
Email
b.scholefield@bham.ac.uk
First Name & Middle Initial & Last Name & Degree
Barney Scholefield, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be stored in the NHLBI data repository after trial completion.
IPD Sharing Time Frame
1 year after publication on main outcome results paper
IPD Sharing Access Criteria
Data use agreement with the appropriate NHLBI repository

Learn more about this trial

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

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