Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism - Full Text View

Sponsored by:	The International Child Development Resrouce Center
Information provided by:	The International Child Development Resrouce Center
ClinicalTrials.gov Identifier:	NCT00263367

Purpose

This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure.

Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism.

This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.

Condition	Intervention
Autism Oxidative Stress	Procedure: Hyperbaric Oxygen

MedlinePlus related topics: Autism

Drug Information available for: Lipids Glutathione

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study

Further study details as provided by The International Child Development Resrouce Center:

Primary Outcome Measures:

reduced glutathione
lipid peroxides

Estimated Enrollment:	10
Study Start Date:	October 2005
Estimated Study Completion Date:	February 2006

Detailed Description:

Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child.

A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber.

These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.

Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children diagnosed with autism ages 5-12 and undergoing hyperbarics

Exclusion Criteria:

Seizures, acute URI, or inability to ventilate ears

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263367

Contacts

Contact: James J Bradstreet, MD FAAFP	321-953-0278	drbradstreet@aol.com
Contact: Esther Kennedy, RN	321-953-0278	ek@gnd.org

Locations

United States, Florida
ICDRC	Recruiting
Melbourne, Florida, United States, 32901

Sponsors and Collaborators

The International Child Development Resrouce Center

Investigators

Principal Investigator:

James J Bradstreet, MD FAAFP

ICDRC

More Information

Primary Location This link exits the ClinicalTrials.gov site

Study ID Numbers:	ICDRC-22.2005
Study First Received:	November 21, 2005
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00263367
Health Authority:	United States: Food and Drug Administration

Keywords provided by The International Child Development Resrouce Center:

Autism
Oxidative Stress
Hyperbaric Oxygen
Reduced Glutathione
Lipid Peroxides

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Stress

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009