Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263367
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2005-11-21
Brief Title:
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Sponsor:
The International Child Development Resource Center
Organization:
The International Child Development Resource Center
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 13 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:
None
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?:
None