NCT00929045

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2007

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

3.4 years

First QC Date

June 24, 2009

Last Update Submit

December 11, 2023

Conditions

Traumatic Brain Injury

Keywords

Growth Hormone replacementsubject 8 to 21moderate to severe traumatic brain injurygrowth hormone deficient

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive changes following moderate/severe TBI

    1 year

Study Arms (1)

Growth Hormone

EXPERIMENTAL
Drug: Growth Hormone Replacement

Interventions

Growth Hormone ReplacementDRUG
Growth Hormone

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Have not completed Phase I of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 26, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share