UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022025 |
|---|---|
| Receipt number | R000025384 |
| Scientific Title | Hyperbaric Oxygen for Autism Spectrum Disorders: A randomized controlled study |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2020/08/02 13:17:35 |
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Basic information
Public title
Hyperbaric Oxygen for Autism Spectrum Disorders: A randomized controlled study
Acronym
hyperbaric oxygen for autism
Scientific Title
Hyperbaric Oxygen for Autism Spectrum Disorders: A randomized controlled study
Scientific Title:Acronym
hyperbaric oxygen for autism
Region
| Africa |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to assess the efficacy of hyperbaric oxygen therapy in relieving symptoms of autism.
Basic objectives2
Others
Basic objectives -Others
Follow up those children by CARS (version 2) for 1 year. It was measured at the beginning of the study, after 6 m and after one year to compare the effect HBOT on ASD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Follow up those children by CARS (version 2) for 1 year. It was measured at the beginning of the study, after 6 m and after one year to compare the effect HBOT on ASD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
HBOT group (I)
Interventions/Control_2
Placebo control group (II)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The present study included Egyptian children with ASD participated in this study. All patients were recruited from the neuropediatric clinics Assiut university hospitals and 5 private centers for autism in Upper Egypt.
Key exclusion criteria
Subjects who had associated other genetic diseases, autoimmune disorders, neurological diseases (such as cerebral palsy and tuberous sclerosis) and metabolic disorders (e.g. phenylketonuria)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Faculty of Medicine - Pediatric Department, Assiut University, Egypt
Division name
Pediatrics
Zip code
71516
Address
Egypt, Assiut city
TEL
+966-599760661
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Faculty of Medicine - Pediatric Department Assiut University
Division name
pediatric neurology
Zip code
71515
Address
Egypt, Assiut city
TEL
+966599760661
Homepage URL
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Assiut University
Address
Assiut University, Egypt
Tel
+20882368373
ahmed.khalifa@med.au.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
120
Results
The results are already obtained
Results date posted
| 2020 | Year | 04 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
still under investigations
Date of the first journal publication of results
Baseline Characteristics
still under investigations
Participant flow
still under investigations
Adverse events
still under investigations
Outcome measures
still under investigations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 22 | Day |
Last modified on
| 2020 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025384
