Autism Clinical Trial
Official title:
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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