MRI Markers of Outcome After Severe Pediatric TBI

Completed

Conditions studied: Brain Injuries

In brief

Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each year in the United States, pediatric TBI results in an estimated 630,000 emergency room visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability after severe TBI is high, with over 60% of children requiring educational or community based supportive services 12 months post-injury. Over 5,000 children require inpatient rehabilitation after TBI each year and an estimated 145,000 US children are currently living with disabilities after a severe TBI. Hospital costs for the acute treatment of children with TBI are estimated at \~$2.6 billion each year, while the gross annual costs accounting for long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a major public health concern and new ways to diagnose and treat TBI are urgently needed.

Key facts

Study ID

NCT02688660

Run by

University of Wisconsin, Madison

People needed

82

Starts

2016-04-01

Expected to finish

2022-05-01

Last updated by the study team

2022-06-24

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aim 1 Subjects:
• Children 0 through < 18 years of age
• Diagnosis of severe TBI (defined as a Glasgow Coma Scale (GCS) score less than or equal to 8)
• Had an intracranial pressure (ICP) monitor as part of standard care
• Aims 2 \& 3 Subjects:
• Children 9 through < 18 years of age with severe TBI
• Consent for a follow-up MRI within 10 years of the time of TBI
• Controls:
• Healthy children greater than or equal to 9 and < 18 years of age.

You may not qualify if…

• TBI \& controls:
• Anyone unable to tolerate a non-sedated MRI
• Controls:
• Any history of head injury resulting in loss of consciousness
• Standard contraindications to MRI (metallic implants, implanted electronic devices, pregnancy, etc.).

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• UC San Diego Health Sciences Center — San Diego, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Tennessee — Knoxville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Primary Children's Medical Center — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• American Family Children's Hospital (AFCH) — Madison, Wisconsin, United States
• The Royal Children's Hospital — Melbourne, Victoria, Australia
• Birmingham Children's Hospital — Birmingham, England, United Kingdom
• University Hospital Southampton — Southampton, Hampshire, United Kingdom

Full record on ClinicalTrials.gov

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