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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3HL159134-01 | U.S. NIH Grant/Contract | View source | |
| U24HL159132 | U.S. NIH Grant/Contract | View source | |
| HUM00206424 | Other Identifier | UM IRB NUMBER |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Kennedy Krieger Institute, Baltimore, MD | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooling 0 hours | Experimental | Participants will be kept at a normal temperature for the whole 5 days. |
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| Cooling 12 hours | Experimental | 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. |
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| Cooling 18 hours | Experimental | 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. |
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| Cooling 24 hours | Experimental | 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. |
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| Cooling 36 hours | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Hypothermia | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after out-of-hospital cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Moler, MD | Contact | 734-764-5302 | fmoler@umich.edu | |
| Moni Weber | Contact | 734-232-4803 | monij@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank Moler, MD | University of Michigan | Principal Investigator |
| Alex Topjian, MD | Children's Hospital of Philadelphia | Principal Investigator |
| William Meurer, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham / Children's of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
The data will be stored in the NHLBI data repository after trial completion.
1 year after publication on main outcome results paper
Data use agreement with the appropriate NHLBI repository
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2023 | Jun 25, 2024 |
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Bayesian Adaptive Design
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The outcomes assessors will be blinded to the treatment assignment of the participant.
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| Cooling 48 hours | Experimental | 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. |
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| Cooling 60 hours | Experimental | 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. |
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| Cooling 72 hours | Experimental | 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. |
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| Cooling 84 hours | Experimental | 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. |
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| Cooling 96 hours | Experimental | 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. |
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| Baseline and 12 months after cardiac arrest |
| 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. | 12 months after cardiac arrest |
| Survival at 12 months | 12 months after cardiac arrest |
| University of Michigan |
| Principal Investigator |
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
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| Banner University Medical Center - Tucson | Active, not recruiting | Tucson | Arizona | 85719 | United States |
| Memorial Health - Miller Children's and Women's Hospital of Long Beach | Recruiting | Long Beach | California | 90806-1701 | United States |
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| Children's Hospital of Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| University of California Los Angeles (UCLA) Mattel Children's Hospital | Recruiting | Los Angeles | California | 90095 | United States |
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| University of California - Oakland / UCSF Benoiff Children's Hospital Oakland | Recruiting | Oakland | California | 94609 | United States |
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| Children's Hospital of Orange County | Recruiting | Orange | California | 92868-4203 | United States |
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| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
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| University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco | Recruiting | San Francisco | California | 94158 | United States |
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| Stanford | Recruiting | Santa Clara | California | 95050 | United States |
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| University of Florida (UF) Health Shands Children's Hospital | Recruiting | Gainesville | Florida | 32610-0296 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33124 | United States |
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| Johns Hopkins All Children's Hospital | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| Ann & Robert Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Comer Children's Hospital, University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Children's Hospital of Illinois | Recruiting | Peoria | Illinois | 61637 | United States |
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| Riley Children's Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Iowa, Carver College of Medicine | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Maryland Children's Hospital | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Johns Hopkins Medicine Children's Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| MassGeneral Hospital for Children | Recruiting | Boston | Massachusetts | 02114 | United States |
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| University of Michigan CS Mott Children's Hospital | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Children's Hospital of Michigan | Recruiting | Detroit | Michigan | 48201 | United States |
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| University of Minnesota Fairview Masonic Children's Hospital | Withdrawn | Minneapolis | Minnesota | 55454 | United States |
| Washington University / St. Louis Children's Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68114 | United States |
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| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| University of Buffalo / Oishei Children's Hospital | Recruiting | Buffalo | New York | 14203 | United States |
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| Cohen Children's Medical Center of NY / Northwell Health | Recruiting | New Hyde Park | New York | 11040 | United States |
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| Mount Sinai Icahn / Kravis Children's Hospital | Recruiting | New York | New York | 10029 | United States |
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| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642-8667 | United States |
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| Montefiore Einstein Hospital Moses Campus | Recruiting | The Bronx | New York | 10467 | United States |
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| The University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599-7220 | United States |
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| Children's Hospital Medical Center of Akron | Recruiting | Akron | Ohio | 44308 | United States |
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| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Ohio State University / Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| Dayton Children's Hospital | Recruiting | Dayton | Ohio | 45404 | United States |
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| Oregon Health & Science University Doernbecher Children's Hospital | Recruiting | Portland | Oregon | 97239 | United States |
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| Penn State University / Penn State Children's Hospital | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Children's Hospital of Pittsburgh (UPMC) | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| University of Tennesses Health Center / Le Bonheur Children's | Recruiting | Memphis | Tennessee | 38104 | United States |
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| Children's Medical Center of Dallas | Recruiting | Dallas | Texas | 75235 | United States |
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| Children's Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| Texas Children's Hospital, Baylor | Recruiting | Houston | Texas | 77030 | United States |
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| The University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Primary Children's Hospital, University of Utah School of Medicine | Withdrawn | Salt Lake City | Utah | 84108 | United States |
| American Family Children's Hospital | Recruiting | Madison | Wisconsin | 53705 | United States |
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| Children's Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Queensland Children's Hospital | Recruiting | Brisbane | Queensland | 4101 | Australia |
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| Townsville University Hospital | Recruiting | Douglas | Queensland | Australia |
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| Gold Coast University Hospital | Recruiting | Southport | Queensland | Australia |
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| Women's and Children's Hospital | Recruiting | North Adelaide | South Australia | 5006 | Australia |
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| Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Royal Children's Hospital | Recruiting | Parkville | Victoria | 3052 | Australia |
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| Perth Children's Hospital | Recruiting | Nedlands | Western Australia | Australia |
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| The Hospital for Sick Children | Recruiting | Toronto | Ontario | Canada |
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| Starship Children's Hospital | Recruiting | Grafton | Auckland | 1142 | New Zealand |
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| Birmingham Children's Hospital, United Kingdom | Recruiting | Birmingham | United Kingdom |
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| Bristol Royal Hospital for Children | Recruiting | Bristol | BS2 8BJ | United Kingdom |
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| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2022 | Jul 3, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D007035 | Hypothermia |
| D020925 | Hypoxia-Ischemia, Brain |
| D003128 | Coma |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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