Clinical trial NCT01763892: Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)
Official title: Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Pediatric
Traumatic Brain Injury
TBI
Apolipoprotein E
apo-E
Vasospasm
Genetics
Physiologic Mechanisms
Neurocognitive Outcomes
Endothelin 1
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of apolipoprotein E (apo-E) allele
timeFrame: Day 1
Secondary outcomes:
measure: Vasospasm detection by Transcranial Doppler Ultrasound (TCD)
timeFrame: 8 days
Other outcomes:
measure: Biomarker Detection
timeFrame: 5 days
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: DUSON
name: Karin Reuter-Rice, PhD
role: PRINCIPAL_INVESTIGATOR
References: