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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
The International Child Development Resource Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
November 21, 2005
Last Updated
June 21, 2011
Sponsor
The International Child Development Resource Center
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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

Learn more about this trial

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

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