A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children (VPH)
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
oxygen (Hyperbaric Oxygen Therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder
Eligibility Criteria
Inclusion criteria:
- Both sexes
- All aged-group
- All educated group
- Diagnosis - Autistic disorder, Autistic spectrums
- Major symptoms - delayed development, delayed speech
Exclusion criteria:
- Uncontrolled severe explosive behaviours
- Uncontrolled organic or physical symptoms such as seizure, ear infection
- Severe phobic or fearful symptoms
- No parent or caretaker
Sites / Locations
- Vachira Phuket Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HBOT
Arm Description
HBOT
Outcomes
Primary Outcome Measures
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Secondary Outcome Measures
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00670891
Brief Title
A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
Acronym
VPH
Official Title
A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vachira Phuket Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.)
General information, the most of sampling groups (75.68%) are female, 40.54% of aged-groups are 30-40 years old, 37.84% of occupations are employee and 32.43% of educations are primary school.
Information about opinion of alternative therapies, the most of parents think that the music therapy is the best way. The second is Chiropractic and the third is Art therapy but Animal therapy with the pony is the least effective way.
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
Administrator's support is provided.
Equipment (HBOT) is in the same place with Development Training Clinic.
Study by professional physicians in various associated experiences and the developmental nurse, psychologist who accustom with children and the parents (caretakers).
Convenience in transportation, which is in a small province.
This HBOT is solitary equipment, governed beneath Thailand Ministry of Public Health.
Disadvantages
Publication in knowledge about HBOT is very low in Thailand.
Harmful may be unknown hidden.
Stigmatization is a delicate point in the parents of these children.
Worrying and guilty feelings are easily occurred in the parents when something may be unexpected happening.
A small province liked Phuket may be difficult to find volunteers for research or study's enrollment.
Information gathering and assessment processes including scoring forms may be underneath standardization and not up-to-date.
Problems-solving plans
Informed knowledge about HBOT, more and more, to the parents and community.
Pre-treatment evaluation was carefully evaluated according to good clinical practice.
Respected to their honour, patient's right and kept confidential of the volunteers.
Reassured the parents and clarified in details of their concerned issues. Explained the strategies explicitly and slowly.
Therefore studied in a small group, closed observation was applied to integrated in details for descriptive study in the volunteers.
It could be a pilot study if their any parts of this study were not clearly understood. And thereafter, study planning in the future will be done in the advance conforming design and methodology following our knowledgeable experiences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBOT
Arm Type
Experimental
Arm Description
HBOT
Intervention Type
Procedure
Intervention Name(s)
oxygen (Hyperbaric Oxygen Therapy)
Other Intervention Name(s)
HBOT
Intervention Description
Current Accepted Applications of HBOT (2008) Jan 2003, ANDI International
Air or Gas Embolus
Decompression Illness
Carbon Monoxide poising
Clostridial Myonecrosis (Gas Gangrene)
Necrotizing Fasciitis
Crush Injury (Compartment syndromes)
Selected Problem Wounds
Compromised Skin Flaps or Grafts
Refractory Osteomyelitis
Exceptional Anemia due to Blood loss
Osteoradionecrosis
Thermal Burns and Radiation Tissue Damage
Diabetic Wounds
Intra-Cranial Abscess
Brain Injury and other Head Trauma
Cerebral Palsy
High Altitude Sickness
Lyme disease
Primary Outcome Measure Information:
Title
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Time Frame
10 sessions assessment
Secondary Outcome Measure Information:
Title
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Time Frame
20 sessions assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Both sexes
All aged-group
All educated group
Diagnosis - Autistic disorder, Autistic spectrums
Major symptoms - delayed development, delayed speech
Exclusion criteria:
Uncontrolled severe explosive behaviours
Uncontrolled organic or physical symptoms such as seizure, ear infection
Severe phobic or fearful symptoms
No parent or caretaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessada Chungpaibulpatana, MD.
Organizational Affiliation
Vachira Phuket Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vachira Phuket Hospital
City
Phuket
ZIP/Postal Code
83000
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
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