Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development
Early Phase 1
Completed
- Conditions
- Traumatic Brain Injury
- Interventions
- Drug: Growth Hormone Replacement
- Registration Number
- NCT00929045
- Lead Sponsor
- University of Virginia
- Brief Summary
The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- This is Phase II trial-subjects have already completed Phase I.
- Traumatic brain injury (TBI).
- Results of the blood work from Phase I shows that your growth hormone levels are low.
Exclusion Criteria
- Have not completed Phase I of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Growth Hormone Growth Hormone Replacement -
- Primary Outcome Measures
Name Time Method Neurocognitive changes following moderate/severe TBI 1 year
- Secondary Outcome Measures
Name Time Method