Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Primary Purpose
Autism, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Oxidative Stress, Hyperbaric Oxygen, Reduced Glutathione, Lipid Peroxides
Eligibility Criteria
Inclusion Criteria: Children diagnosed with autism ages 5-12 and undergoing hyperbarics Exclusion Criteria: Seizures, acute URI, or inability to ventilate ears
Sites / Locations
- ICDRC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
hyperbaric oxygen at 1.3 ATA
Arm Description
Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood
Outcomes
Primary Outcome Measures
glutathione
measurement of glutathione immediately after one hour of exposure to low dose HBOT
Secondary Outcome Measures
Full Information
NCT ID
NCT00263367
First Posted
November 21, 2005
Last Updated
June 21, 2011
Sponsor
The International Child Development Resource Center
1. Study Identification
Unique Protocol Identification Number
NCT00263367
Brief Title
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Official Title
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The International Child Development Resource Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Oxidative Stress
Keywords
Autism, Oxidative Stress, Hyperbaric Oxygen, Reduced Glutathione, Lipid Peroxides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyperbaric oxygen at 1.3 ATA
Arm Type
Other
Arm Description
Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen
Other Intervention Name(s)
HBOT
Intervention Description
Hyperbaric Oxygen at 1.3 ATA for one hour
Primary Outcome Measure Information:
Title
glutathione
Description
measurement of glutathione immediately after one hour of exposure to low dose HBOT
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with autism ages 5-12 and undergoing hyperbarics
Exclusion Criteria:
Seizures, acute URI, or inability to ventilate ears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Bradstreet, MD FAAFP
Organizational Affiliation
ICDRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDRC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
12. IPD Sharing Statement
Links:
URL
http://icdrc.org
Description
Primary Location
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Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
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