Protocol for Long Term Study of Brain Injury in Children - Blood, Serum, CSF and DNA Repository and Database

Study ID
STU 122010-110

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Andrew Hebert

Principal Investigator
Darryl Miles, M.D.


Specific aims in this project:
1. Collect Dna for candidate single nucleotide polymorphism (SnP) analysis.

2. Determine outcomes of children suffering from TBi with multiple metrics, including rehabilitation assessment/progress notes during inpatient stay and routine outpatient follow-up visits. Data from neuropsychological outcome testing will also be collected and correlated. neuropsychological follow-up occurs at discharge, 3, 6, and 12 months post-injury as standard follow-up care. There will also be a 2 year and 5 year neuropsychological follow-up to evaluate long-term outcomes. The 2 and 5 year follow-up will consist of the same assessments performed for the 6 and 12 month evaluations. Refer to appendix 1 for a list of standard neuropsychological testing at various stages.

3. Correlate outcome data with genetic data stratified by age and gender.

4. Collect outcome data for all study participants, whether or not they consent to the Dna sample collection. This data collection will occur at discharge, 3, 6, and 12 months and at the 2 and 5 year follow-up post-injury, as specified in aim #2.

Participant Eligibility

* Children admitted to Children[Single Quote]s Medical Center Dallas for observation or treatment of a traumatic brain injury caused by blunt force

* Traumatic brain injury must be the primary diagnosis. The Glasgow Coma Scale, which measures severity, must be a 12 or less. Thus, children with moderate (GCS of 9-12), and severe (GCS of 8 or less) traumatic brain injuries will be included.

* Evidence of intracranial injury on head CT or brain MRI
* Newborn to 17 years of age

* Any race or gender

* Parental consent. Assent will be obtained once child is cognitively able to provide assent.