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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929045

Enrollment

Registered

2009-06-26

Start date

2007-07-31

Completion date

2010-12-31

Last updated

2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

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

Brief 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.

Interventions

DRUGGrowth Hormone Replacement

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 21 Years

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

* Have not completed Phase I of the study.

Design outcomes

Primary

Measure	Time frame
Neurocognitive changes following moderate/severe TBI	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026