Phase
Condition
Brain Injury
Hemorrhage
Neurologic Disorders
Treatment
Questionnaires
Clinician / Medical Record Variables
Validated Questionnaires
Clinical Study ID
Ages 11-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with:
- Head injury (e.g., direct blow or sudden deceleration/acceleration) plus any neurological sign and/or symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms/signs)
AND/OR
- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)
*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and/or have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as "concussion" or "minor head injury". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study.
Exclusion
Exclusion Criteria:
Presentation to the ED >72 hours post-injury
TBI requiring emergent neurosurgical intervention at the time of enrollment
Other injuries requiring emergent surgery at the time of enrollment
Parent or child unable to accurately complete the study questionnaires due topreexisting functional limitations (e.g., severe developmental delay)
Previous known enrollment into the study
Patient or parent does not speak English or Spanish
Study Design
Study Description
Connect with a study center
University of California, Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
University of California, Davis Medical Center
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Hasbro Children's Hospital and Brown University
Providence, Rhode Island 02903
United StatesSite Not Available
Hasbro Children's Hospital and Brown University
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
University of Texas Southwestern Medical Center - Children's Health
Dallas, Texas 75390
United StatesSite Not Available
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
Baylor College of Medicine, Texas Children's Hospital
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Children's Hospital of Wisconsin-Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53226
United StatesSite Not Available
The Medical College of Wisconsin, Inc.
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting

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