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

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Growth Hormone Replacement

Drug

Primary outcomes

Neurocognitive changes following moderate/severe TBI

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

National Institutes of Health (NIH)
Virginia Commonwealth University

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jun 26, 2009
Registry last updated: Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed