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

University of Virginia

Status and phase: Completed; Early Phase 1

Conditions: Traumatic Brain Injury

Treatments: Drug: Growth Hormone Replacement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00929045

13239

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Growth Hormone

Experimental group

Treatment:

Drug: Growth Hormone Replacement