UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051965 |
|---|---|
| Receipt number | R000059105 |
| Scientific Title | Registry Research Study on Acute Encephalopathy and Febrile Convulsions |
| Date of disclosure of the study information | 2023/08/22 |
| Last modified on | 2023/08/22 00:45:51 |
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Basic information
Public title
Registry Research Study on Acute Encephalopathy and Febrile Convulsions
Acronym
Registry Research Study on Acute Encephalopathy and Febrile Convulsions
Scientific Title
Registry Research Study on Acute Encephalopathy and Febrile Convulsions
Scientific Title:Acronym
Registry Research Study on Acute Encephalopathy and Febrile Convulsions
Region
| Japan | Asia(except Japan) |
Condition
Condition
acute encephalopathy, febrile seizure
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Build-up of accumulated cases of acute encephalopathy, febrile convulsions, and status epilepticus
Basic objectives2
Others
Basic objectives -Others
follow-up of neurological outcomes
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
not applicable due to the nature of the study design.
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 | months-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who fulfill the following (1) and (2)
(i) Those who were hospitalized with a chief complaint of impaired consciousness/convulsions associated with fever, or with a final diagnosis of acute encephalopathy, or with status epilepticus.
(ii) Those who are between 1 month old and 18 years old (at the time of onset of illness)
Key exclusion criteria
(1) Patients who have requested not to participate in this study
(ii) Patients who are judged to be inappropriate as subjects by the principal investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagase |
Organization
Kobe University Graduate School of medicine
Division name
Department of Pediatrics
Zip code
6500017
Address
7-5-2 Kusunokucho, Chuo-ku, Kobe-shi
TEL
+8178-382-6090
nagase@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagase |
Organization
Kobe University Graduate School of medicine
Division name
Department of Pediatrics
Zip code
6500017
Address
7-5-2 Kusunokucho, Chuo-ku, Kobe-shi
TEL
+8178-382-6090
Homepage URL
nagase@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
ministry of health labour and welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital, Clinical and translational research center.
Address
7-5-2 Kusunokucho, Chuo-ku, Kobe-shi
Tel
+8178-382-6669
chiken@med.kobe-u.ac.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
| 2023 | Year | 08 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A registry study describing the clinical course, laboratory findings, treatment, diagnoses, and outcomes of all eligible patients admitted to participating facilities.
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059105
