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| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2008 | ||||
| Last Updated Date | May 26, 2008 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 10 sessions assessment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00670891 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 20 sessions assessment ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children | ||||
| Official Title ICMJE | A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children | ||||
| Brief Summary | Autism is a developmental and behavioral pattern which includes the triad of impairments, 1. social interaction 2. social communication 3. imagination. Inevitable difficulties in the treatment, managing and handle with autistic children are the main problems. Their memories are seemingly in picture or photo records, which are difference from normal population. There are many concepts but no concise in causative factors, including useful treatments, useless and prolong remaining in many studies. HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change in oxygen can make the better improvements in : cognitive ability, socialization, sleep, calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds (mercury) to improve the autism. This clinical trial study divided into 3 group populations 1. general autism 2. post-treatment chiropractic autism 3. medicated autism. This comparative study shows the major clinical symptoms before and after the treatment with HBOT. This study results and analysis are the most important for our further projects planning. |
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| Detailed Description | Detailed Description There is a general agreement that early identification of autistic spectrum disorders in children and intervention is extremely important. We would like to find out beneficial effects for early identification and treatment in the autism. Another meaning, it declares that the autism is treatable and can be prevention in the early stage of the symptoms. According to many studies, they had shown brain injury could be caused by heavy metal effects, chemical poisoning, infection, autoimmune response, poor blood flow, lack of oxygen. There are many alternative therapies that were claimed to have some effects to make better results in autistic symptoms, but no definite one which could absolutely cured to the autism. HBOT (Hyperbaric Oxygen Therapy) is a new way in the treatment for decompression sickness syndrome (Caisson disease) and it can be applied to intervene or concomitant treatments with some symptoms such as diabetic wounds, burnt wounds. Vachira Phuket Hospital, HBOT center and child development center was established in 2002. This HBOT center is the only one stand-alone center of provincial hospitals in Thailand. Enthusiastic questions in our proceedings were how to declare our opportunities to be a center in HBOT and child developmental center. If HBOT can be an effective method in alternative therapies, we can help our numerous autistic children. In our proceeding study we found that HBOT was the least interesting method of alternative therapies for the autism in parental opinions. (Figure 1.)
In the topic of the knowledge about Alternative therapies, the most of parents know about Chiropractic, Art therapy and Music therapy as sequence. The parents know Hyperbaric Oxygen Therapy as the least. They interested in Music therapy, Chiropractic and Art therapy as sequence. But they are interested in animal therapy with pony and dog as the least. The researchers think that the parents' knowledge about each therapy affects their decision making to choose for their children. Vachira Phuket Hospital has Hyperbaric oxygen therapy (Chamber) which is the new therapy for Autistic children but the parents don't have the knowledge about it. So, the researchers wonder how should we give the information to the parents in order to get the most benefit from this therapy. Figure 1. Autistic parental attitude surveys in effective, knowledge and interesting in various therapies at Vachira Phuket Hospital, July 2007 Whatever it is our opportunities to prove how effective of HBOT in the treatment for autism and represent autistic pathology mechanisms in preceding hypotheses. Advantages
Disadvantages
Problems-solving plans
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Autistic Disorder | ||||
| Intervention ICMJE | Procedure: oxygen (Hyperbaric Oxygen Therapy) | ||||
| Study Arms / Comparison Groups | Experimental: HBOT | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 7 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 9 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00670891 | ||||
| Responsible Party | HBOT and Developmental Clinic Team, Vachira Phuket Hospital | ||||
| Study ID Numbers ICMJE | VP 000001 | ||||
| Study Sponsor ICMJE | Vachira Phuket Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Vachira Phuket Hospital | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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