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临床试验/NCT01763892
NCT01763892已完成不适用

Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

Duke University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Presence of apolipoprotein E (apo-E) allele

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Days 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Presence of apolipoprotein E (apo-E) allele

时间窗: Day 1

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

次要结局

  • Vasospasm detection by Transcranial Doppler Ultrasound (TCD)(8 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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