UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018739 |
|---|---|
| Receipt number | R000021682 |
| Scientific Title | Epidemiological studies on pediatric Guillain-Barre syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2021/03/05 22:01:48 |
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Basic information
Public title
Epidemiological studies on pediatric Guillain-Barre syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis
Acronym
Epidemiological studies on pediatric Guillain-Barre syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis
Scientific Title
Epidemiological studies on pediatric Guillain-Barre syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis
Scientific Title:Acronym
Epidemiological studies on pediatric Guillain-Barre syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis
Region
| Japan |
Condition
Condition
Guillain-Barré syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis of children
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence, clinical manifestations and epidemiological features of Guillain-Barré syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis of children
Basic objectives2
Others
Basic objectives -Others
Incidence, Epidemiology, Symptomatology, Epidemiology, Therapy, Prognosis
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate incidence, clinical manifestations, laboratory data, therapies, and prognosis of Guillain-Barré syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet the diagnostic criteria of Guillain-Barré syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis, respectively.
Key exclusion criteria
Patients who are not suitable for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fujii |
| Middle name | |
| Last name | Katsunori |
Organization
Chiba University Graduate School of Medicine
Division name
Pediatrics
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, 260-8670, Japan
TEL
+81(43)226-2144
kfujii@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Fujii |
| Middle name | |
| Last name | Katsunori |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, 260-8670, Japan
TEL
+81(43)226-2144
Homepage URL
http://www.pediatrics-chiba-u.org/
kfujii@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Department of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
+81432262144
kfujii@faculty.chiba-u.jp
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
千葉大学大学院医学研究院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
103
Results
We obtained responses from 538 pediatric neurology specialists (50.4%). The total number of GBS, FS, and BBE children in Japan for three years from 2014 to 2016 were 87, 10, and 6, respectively. These indicated that the annual incidence (0-14 years) with childhood population was 0.19 per 100,000 in GBS, 0.023 per 100,000 in FS and 0.0071 per 100,000 in BBE.widely distributed.
Results date posted
| 2021 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pediatric neurologist in Japan
Participant flow
Reply to the questionnaire
Adverse events
none
Outcome measures
Hughes Functional Grade Scale
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 30 | Day |
Other
Other related information
We are going to collect clinical information of other pediatric diseases mimicking Guillain-Barré syndrome, Fisher syndrome, and Bickerstaff brainstem encephalitis.
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021682
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
