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

Early Phase 1CompletedNCT00929045

University of Virginia8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Growth Hormone ReplacementDRUG

Eligibility

Sex: ALLMin age: 8 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Neurocognitive changes following moderate/severe TBI

Time frame: 1 year

Data from ClinicalTrials.gov

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