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Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263367
First Posted: December 8, 2005
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The International Child Development Resource Center
  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 Other: Hyperbaric Oxygen

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • glutathione [ Time Frame: 1 hour ]
    measurement of glutathione immediately after one hour of exposure to low dose HBOT


Enrollment: 10
Study Start Date: October 2005
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hyperbaric oxygen at 1.3 ATA
Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood
Other: Hyperbaric Oxygen
Hyperbaric Oxygen at 1.3 ATA for one hour
Other Name: HBOT

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263367


Locations
United States, Florida
ICDRC
Melbourne, Florida, United States, 32901
Sponsors and Collaborators
The International Child Development Resource Center
Investigators
Principal Investigator: James J Bradstreet, MD FAAFP ICDRC
  More Information

Additional Information:
Responsible Party: James Bradstreet MD, ICDRC
ClinicalTrials.gov Identifier: NCT00263367     History of Changes
Other Study ID Numbers: ICDRC-22.2005
First Submitted: November 21, 2005
First Posted: December 8, 2005
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by The International Child Development Resource Center:
Autism
Oxidative Stress
Hyperbaric Oxygen
Reduced Glutathione
Lipid Peroxides

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders