Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

NCT ID: NCT01763892

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children admitted to hospital with a TBI

non-intervention study

No interventions assigned to this group

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

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Reuter-Rice, PhD

Role: PRINCIPAL_INVESTIGATOR

DUSON

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

71244

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1P30NR014139-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00040284

Identifier Type: -

Identifier Source: org_study_id