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Completed

NCT Number: NCT01763892

Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

5 day–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit
  • Range in age from birth to 15 years
  • TBI with a Glasgow Coma Scale of 3-15
  • Acoustic window for adequate transcranial doppler (TCD) ultrasound
  • English or Spanish speaking or understanding parent/legal guardian to consent
  • Access for a buccal swab for genotyping

Exclusion criteria

  • Non-English or Spanish speaking parents/legal guardian
  • Children with a previously diagnosed neurodevelopmental delay

Treatment and study plan

Primary outcomes

  1. Presence of apolipoprotein E (apo-E) allele

    Time frame: Day 1

    Collection of Apo-E allele will be obtained by buccal swab upon enrollment

Secondary outcomes

  1. Vasospasm detection by Transcranial Doppler Ultrasound (TCD)

    Time frame: 8 days

    Daily Transcranial doppler ultrasound will performed in pediatric traumatic brain injury patients through hospital day 8. If vasospasm is present and persists beyond hospital day 8, daily TCD examinations will be continued until resolution of vasospasm is noted.

Other outcomes

  1. Biomarker Detection

    Time frame: 5 days

    Detection of a defined set of protein biomarkers from biological samples collected at baseline, 24, 48, and 96 hours.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2013
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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