Status:
RECRUITING
Brain Injury Education and Outpatient Navigation-1stBIEN
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Brain Injuries, Traumatic
Rehabilitation
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief Summary
Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality...
Detailed Description
TBI is a major cause of acquired disability in children. Approximately 60% of children with moderate to severe TBI have long-term cognitive, emotional, or physical deficits. Compared to non-Hispanic c...
Eligibility Criteria
Inclusion
- Children Inclusion criteria:
- Children 3 to 17 years of age,
- Hispanic ethnicity
- Diagnosis of mild, moderate or severe TBI.
- Hospitalization at one of the 5 academic institutions participating in this trial,
- Treatment requiring at least one type of rehabilitation therapy as outpatient
- Parent Inclusion Criteria:
- Hispanic ethnicity
- Being the primary caregiver for the child (For longitudinal follow-up purposes)
- Exclusion criteria:
- Child:
- Prior neurological deficits,
- Acquired brain injuries secondary to other conditions different from trauma.
- Traumatic brain injuries secondary to abusive trauma.
- Parent:
- Loss of custody of the child (i.e. abusive head trauma)
- Inability to be contacted by phone
Exclusion
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05261477
Start Date
July 7 2022
End Date
December 1 2026
Last Update
May 13 2025
Active Locations (6)
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1
Children's Hospital Colorado
Colorado Springs, Colorado, United States, 80920
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
4
University of Utah
Salt Lake City, Utah, United States, 84112