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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Oxidative Stress

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICDRC

Melbourne, Florida, 32901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children diagnosed with autism ages 5-12 and undergoing hyperbarics

Exclusion criteria

Seizures, acute URI, or inability to ventilate ears

Treatment and study plan

Hyperbaric oxygen

Other

Hyperbaric Oxygen at 1.3 ATA for one hour

Other names: HBOT

Primary outcomes

glutathione

Time frame: 1 hour

measurement of glutathione immediately after one hour of exposure to low dose HBOT

Sponsors and collaborators

Lead sponsor

The International Child Development Resource Center

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Dec 8, 2005
Registry last updated: Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed