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Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Growth Hormone Replacement
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Growth Hormone replacement, subject 8 to 21, moderate to severe traumatic brain injury, growth hormone deficient

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Growth Hormone

Arm Description

Outcomes

Primary Outcome Measures

Neurocognitive changes following moderate/severe TBI

Secondary Outcome Measures

Full Information

First Posted
June 24, 2009
Last Updated
April 12, 2010
Sponsor
University of Virginia
Collaborators
Commonwealth Neurotrauma Initiative (Commonwealth of Virginia), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00929045
Brief Title
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development
Official Title
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
Commonwealth Neurotrauma Initiative (Commonwealth of Virginia), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Growth Hormone replacement, subject 8 to 21, moderate to severe traumatic brain injury, growth hormone deficient

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Growth Hormone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Growth Hormone Replacement
Primary Outcome Measure Information:
Title
Neurocognitive changes following moderate/severe TBI
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter D Patrick, PhD
Phone
434-924-5411
Email
pdp2n@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jodi G Darring, BS
Phone
434-982-3673
Email
jgd7s@virginia.edu
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi G Darring, BS
Phone
434-982-3673
Email
jgd7s@virginia.edu
First Name & Middle Initial & Last Name & Degree
Peter D Patrick, PhD

12. IPD Sharing Statement

Learn more about this trial

Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

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