UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039047 |
|---|---|
| Receipt number | R000044528 |
| Scientific Title | Febrile Seizure Owing to Premature Blood-Brain Barrier Integrity: A New Mechanism |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2023/07/07 11:05:38 |
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Basic information
Public title
Febrile Seizure Owing to Premature Blood-Brain Barrier Integrity: A New Mechanism
Acronym
Febrile Seizure: A New Mechanism
Scientific Title
Febrile Seizure Owing to Premature Blood-Brain Barrier Integrity: A New Mechanism
Scientific Title:Acronym
Febrile Seizure: A New Mechanism
Region
| Japan |
Condition
Condition
Febrile seizure
Classification by specialty
| Neurology | Pediatrics | Emergency medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism of febrile seizure
Basic objectives2
Others
Basic objectives -Others
Blood-brain barrier integrity in children with febrile seizures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood-brain barrier integrity in children with febrile seizures
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
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with febrile seizures
Key exclusion criteria
Contraindication for MRI
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Toyokawa City Hospital
Division name
Neurology
Zip code
442-08571
Address
23 Noji Yawata Toyokawa
TEL
0533-86-1111
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Kito |
Organization
Toyokawa City Hospital
Division name
Neurology
Zip code
442-08571
Address
23 Noji Yawata Toyokawa
TEL
0533-86-1111
Homepage URL
kitomrn@toyokawa-ch-aichi.jp
Sponsor or person
Institute
Toyokawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyokawa City Hospital
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
Toyokawa City Hospital
Address
23 Noji Yawata Toyokawa
Tel
0533-86-1111
uchidayuto0720@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2020 | Year | 01 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044528
| Research Plan | |
|---|---|
| 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 |
