Brief Summary

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach

6 countries

30 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

September 16, 2005

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed

2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed

Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

3.5 years

First QC Date

September 16, 2005

Last Update Submit

July 10, 2012

Conditions

Traumatic Brain Injury

Keywords

hypothermiapediatric TBI

Outcome Measures

Primary Outcomes (1)

The primary specific aim of this RCT is to determine the effect of induced moderate HYPO (32-33 °C) after severe TBI in children on mortality.
3 month post injury

Secondary Outcomes (3)

To determine the effect of HYPO after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability/development, memory and learning, and behavior.
at 6 and 12 months post injury
To determine the effect of HYPO after severe TBI in children of different age ranges (< 6y; 6-<16y; and 16-<18y) on mortality and 6 and 12 months functional and neurocognitive outcomes.
3, 6 and 12 months post injury
To determine the effect of HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP).
7 days post injury

Study Arms (1)

A

EXPERIMENTAL

Induced moderate hypothermia (32-33 C)

Procedure: induced moderate hypothermia

Interventions

induced moderate hypothermiaPROCEDURE

Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.

Eligibility Criteria

AgeUp to 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Patients with a GCS \</= 8
Glasgow Motor Score \< 6
Closed head injury
Age 0 \< 18 y

You may not qualify if:

Unavailable to initiate cooling within 6 hours of injury
Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function
Normal initial CT scan (No blood, fracture, swelling, and/or shift)
Penetrating brain injury
No known mechanism of injury
Unknown time of injury
Uncorrectable coagulopathy (PT/PTT \> 16/40 sec, INR \> 1.7)
Hypotensive episode (Systolic Blood Pressure \<5th percentile for age\>10 min)
Documented Hypoxic episode (O2 saturation \< 94% for \> 30 min)
Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Phoenix Children's Hospitallead
National Institutes of Health (NIH)collaborator

Study Sites (30)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cohen's Children's Hospital

New Hyde Park, New York, 11040, United States

Location

Weill Cornell Medical Center

New York, New York, 10950, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 47229-3039, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh/Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75235, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Sydney Children's Hospital, Randwick

Sydney, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital, Brisbane

Brisbane, Queensland, 4029, Australia

Location

Mater Children's Hospital

Brisbane, Queensland, 4101, Australia

Location

Children's Youth and Women's Health Service

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital Melbourne

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Subiaco, Perth, Western Australia, 6008, Australia

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V4A 5X3, Canada

Location

Starship Children's Hospital

Auckland, 1023, New Zealand

Location

University of Cape Town

Rondebosch, Cape Town, 7700, South Africa

Location

Institute of Child Health, Univ. College London & Great Ormond

Bloomsbury, London, WC1N 3JH, United Kingdom

Location

Birmingham Children's Hospital

Birmingham, West Midlands, UK B4 6NH, United Kingdom

Location

Related Publications (2)

Meinert E, Bell MJ, Buttram S, Kochanek PM, Balasubramani GK, Wisniewski SR, Adelson PD; Pediatric Traumatic Brain Injury Consortium: Hypothermia Investigators. Initiating Nutritional Support Before 72 Hours Is Associated With Favorable Outcome After Severe Traumatic Brain Injury in Children: A Secondary Analysis of a Randomized, Controlled Trial of Therapeutic Hypothermia. Pediatr Crit Care Med. 2018 Apr;19(4):345-352. doi: 10.1097/PCC.0000000000001471.
PMID: 29370008DERIVED
Adelson PD, Wisniewski SR, Beca J, Brown SD, Bell M, Muizelaar JP, Okada P, Beers SR, Balasubramani GK, Hirtz D; Paediatric Traumatic Brain Injury Consortium. Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial. Lancet Neurol. 2013 Jun;12(6):546-53. doi: 10.1016/S1474-4422(13)70077-2. Epub 2013 May 8.
PMID: 23664370DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticHypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

P. David Adelson, MD
Phoenix Children's Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

November 1, 2007

Primary Completion

May 1, 2011

Study Completion

March 1, 2012

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

GB(2)NZ(1)AU(7)CA(2)US(17)ZA(1)

Study Stopped

Hypothermia in Children After Trauma

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations