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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by University of Virginia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929045
First Posted: June 26, 2009
Last Update Posted: April 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Commonwealth Neurotrauma Initiative (Commonwealth of Virginia)
General Clinical Research Center (NIH)
Information provided by:
University of Virginia
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Neurocognitive changes following moderate/severe TBI [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peter D. Patrick, Ph.D., University of Virginia
ClinicalTrials.gov Identifier: NCT00929045     History of Changes
Other Study ID Numbers: 13239
First Submitted: June 24, 2009
First Posted: June 26, 2009
Last Update Posted: April 14, 2010
Last Verified: April 2010

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:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones
Mitogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action