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

This study has been completed.
Sponsor:
Information provided by:
The International Child Development Resource Center
ClinicalTrials.gov Identifier:
NCT00263367
First received: November 21, 2005
Last updated: June 21, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: James Bradstreet MD, ICDRC
ClinicalTrials.gov Identifier: NCT00263367     History of Changes
Other Study ID Numbers: ICDRC-22.2005
Study First Received: November 21, 2005
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

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
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 25, 2014