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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

NCT ID: NCT00929045

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Growth Hormone

Group Type EXPERIMENTAL

Growth Hormone Replacement

Intervention Type DRUG

Interventions

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Growth Hormone Replacement

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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13239

Identifier Type: -

Identifier Source: org_study_id