Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any - 15
Updated:4/21/2016
Start Date:December 2012
End Date:September 2015

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The aims of this study explore the relationships between cerebral vasospasm,
apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that
may either intensify or ameliorate secondary injury, for children with a traumatic brain
injury. Exploring the apo-E genotype will help us know if injury response is altered in
certain children and will aid in developing interventional approaches.

The purpose of this study is to advance knowledge of neurocognitive outcomes in pediatric
traumatic brain injury (TBI) patients by exploring the relationships between physiologic
factors of cerebral vasospasm, apolipoprotein E (apo-E) allele, biomarkers, and
neurocognitive outcomes. This study is a funded project within Duke University School of
Nursing National Institutes of Health/National Institute of Nursing Research (NIH/NINR) P30
Center of Excellence Grant. This study will continue on with some of the work of a small
intramural grant study determining the feasibility of conducting pediatric TBI research at
DUHS. It will advance the measurement of vasospasm by translating the use of the
Transcranial Doppler (TCD) ultrasound to neuromonitoring in children. To date, this will be
the first pediatric study examining the relationship of cerebral vasospasm, apo-E, and
biomarkers with neurocognitive outcomes. Unlike adult TBI patients, cerebral vasospasm,
apo-E, and biomarker collections have yet to be examined in pediatric neurotrauma patients
in the Duke University Health System. Although neurocognitive outcomes are a standard of
care for TBI patients at Duke University Health System (DUHS), the data has yet to be
examined within the realm of pediatric neurodiagnostic physiologic measures. By obtaining
preliminary data in 35 patients, it will allow for the evaluation of multi-diagnostic
measures in pediatric TBI patients, as well as provide data for future funding for a larger
regionally-scale study.

Inclusion Criteria:

1. TBI patients admitted to the pediatric intensive care service (PICU)or pediatric
progressive care unit

2. Range in age from birth to 15 years

3. TBI with a Glasgow Coma Scale of 3-15

4. Acoustic window for adequate transcranial doppler (TCD) ultrasound

5. English or Spanish speaking or understanding parent/legal guardian to consent

6. Access for a buccal swab for genotyping

Exclusion Criteria:

1. Non-English or Spanish speaking parents/legal guardian

2. Children with a previously diagnosed neurodevelopmental delay
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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