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CompletedNCT00929045Updated Dec 18, 2023

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

An Early Phase 1 interventional study of Growth Hormone Replacement in Traumatic Brain Injury, sponsored by University of Virginia. Completed. Open to participants aged 8 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by University of Virginia · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
8 Years to 21 Years
Sex
All
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Study 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.

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Conditions studied

  • Traumatic Brain Injury

Keywords

  • Growth Hormone replacement
  • subject 8 to 21
  • moderate to severe traumatic brain injury
  • growth hormone deficient
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 8 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Have not completed Phase I of the study.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Growth Hormone

    Drug: Growth Hormone Replacement

Interventions

  • DrugGrowth Hormone Replacement
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What researchers measure

Primary outcomes

  1. Neurocognitive changes following moderate/severe TBI

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00929045
Lead sponsor
University of Virginia
Collaborators
Virginia Commonwealth University, National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jun 26, 2009
Start date
Jul 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 18, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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