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

Not Applicable

Completed

• Conditions: Autism; Oxidative Stress
• Interventions: Other: Hyperbaric Oxygen

• Registration Number: NCT00263367
• Lead Sponsor: The International Child Development Resource Center

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-08
• Primary Completion: 2006-01
• Study Completion: 2006-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children diagnosed with autism ages 5-12 and undergoing hyperbarics

Exclusion Criteria

• Seizures, acute URI, or inability to ventilate ears

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hyperbaric oxygen at 1.3 ATA	Hyperbaric Oxygen	Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood

Primary Outcome Measures

Name	Time	Method
glutathione	1 hour	measurement of glutathione immediately after one hour of exposure to low dose HBOT

Trial Locations

Locations (1)

ICDRC; 🇺🇸 Melbourne, Florida, United States