Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00263367
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2005-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Sponsor:
The International Child Development Resource Center
Organization:
Study Overview
Official Title:
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: