NCT00731887

Brief Summary

To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 30, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 8, 2014

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

July 30, 2008

Last Update Submit

January 7, 2014

Conditions

Burns

Keywords

Burn injuryBurn recovery

Interventions

Blood and urine testingPROCEDURE

complete blood count, routine chemistries, liver function test, retinol binding protein, transferrin, prothrombin time, partial thromboplastin time, fibrinogen, Vitamin A and Zinc, Insulin Growth Factor levels and binding proteins, cytokines (interleukins 1, 6, 12), insulin, thyroid hormones, cortisol, 25-hydroxyvitamin D, and osteocalcin.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those that have received a burn injury at least 3 years ago and that recieved acute burn treatment at Shriners Hospital for Children - Galveston between 1986-2005.

You may qualify if:

  • At least 60% third degree total body surface area
  • Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
  • Three years post injury
  • Current age of at least 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine collected for this study will be retained for possible re-analysis if needed for the duration of the study.

MeSH Terms

Conditions

Burns

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 11, 2008

Study Start

June 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 8, 2014

Record last verified: 2013-12