UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022025
Receipt No. 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 (Ver. 19)

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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
Email 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
Email khaled.ali@med.au.edu.eg

Sponsor
Institute Self funding
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025384