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

Autism Clinical Trial

Official title:

Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263367
• Other study ID #: ICDRC-22.2005
• Status: Completed
• Phase: N/A
• First received: November 21, 2005
• Last updated: June 21, 2011
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: June 2011
• Source: The International Child Development Resource Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Seizures, acute URI, or inability to ventilate ears

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Oxidative Stress

Intervention

Other:
• Hyperbaric Oxygen
Hyperbaric Oxygen at 1.3 ATA for one hour

Locations

Country	Name	City	State
United States	ICDRC	Melbourne	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The International Child Development Resource Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glutathione	measurement of glutathione immediately after one hour of exposure to low dose HBOT	1 hour	Yes

External Links

•   Primary Location