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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Commonwealth Neurotrauma Initiative (Commonwealth of Virginia)
General Clinical Research Center (NIH)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00929045
First received: June 24, 2009
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
 Drug: Growth Hormone Replacement
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Neurocognitive changes following moderate/severe TBI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: July 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth Hormone Drug: Growth Hormone Replacement

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929045

Contacts
Contact: Peter D Patrick, PhD 434-924-5411 pdp2n@virginia.edu
Contact: Jodi G Darring, BS 434-982-3673 jgd7s@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jodi G Darring, BS     434-982-3673     jgd7s@virginia.edu    
Principal Investigator: Peter D Patrick, PhD            
Sponsors and Collaborators
University of Virginia
Commonwealth Neurotrauma Initiative (Commonwealth of Virginia)
General Clinical Research Center (NIH)
  More Information

No publications provided

Responsible Party: Peter D. Patrick, Ph.D., University of Virginia
ClinicalTrials.gov Identifier: NCT00929045     History of Changes
Other Study ID Numbers: 13239
Study First Received: June 24, 2009
Last Updated: April 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Growth Hormone replacement
subject 8 to 21
moderate to severe traumatic brain injury
growth hormone deficient

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
 Mitogens
Hormones
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013