UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040644 |
|---|---|
| Receipt number | R000046389 |
| Scientific Title | Prospective survey for acute encephalopathy with biphasic seizures and late reduced diffusion among children with prolonged febrile seizures |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/12/06 13:54:13 |
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Basic information
Public title
Prospective survey for acute encephalopathy among children with prolonged febrile seizures
Acronym
AESD in PFS
Scientific Title
Prospective survey for acute encephalopathy with biphasic seizures and late reduced diffusion among children with prolonged febrile seizures
Scientific Title:Acronym
AESD in PFS
Region
| Japan |
Condition
Condition
prolonged febrile seizure, acute encephalopathy with biphasic seizures and late reduced diffusion
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence and risk factors of acute encephalopathy with biphasic seizures and late reduced diffusion among pediatric patients with prolonged febrile seizures.
Basic objectives2
Others
Basic objectives -Others
Observational study before intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of AESD among Incidence of AESD among less than 2 year-old children with prolonged febrile seizures (>40min).
Key secondary outcomes
Comparison of initial condition between less than 2 year-old children with prolonged febrile seizures (>40min) and those with AESD.
Sensitivity and specificity of the AESD predictive score
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
| Not applicable |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients less than two year-old
(2) Patients with prolonged febrile seizuresof longer than 40min
(3) Patients who had written informed consent from their guardians
Key exclusion criteria
(1) Patients with severe brain edema or coagulopathy
(2) Patients with cerebrospinal leukocytosisof more than 15/microL
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Muneaki |
| Middle name | |
| Last name | Matsuo |
Organization
Saga University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952242314
matsuo@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Muneaki |
| Middle name | |
| Last name | Matsuo |
Organization
Saga University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952242314
Homepage URL
matsuo@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Saga University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952242314
clinstudycenter@mail.admin.saga-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
| 2020 | Year | 07 | Month | 01 | 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
125
Results
We conducted a prospective investigation into the occurrence of AESD in children under 2 years of age with febrile status convulsions lasting 40 minutes or longer, and found that 16 (12.8%) of 125 cases had AESD.
Results date posted
| 2023 | Year | 12 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The analysis of the data would be delay because of delayed collection of the results.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Information to be collected
(1)Age, gender
(2)Time from fever onset to seizue onset
(3) The duration of the seizure
(4) Pre-existed disorder
(5) Treatment
(6) Hight, Weight
(7) Vital sign
(8) Developmental delay
(9) Rapid viral test result
(10) CBC
(11) TP, Alb,BUN, Cr, UA, CRP, Na, K, Cl, AST, ALT, LD, GGTP, ALP, BS, NH3, Lac, PCT
(12) Blood gas
(13) Zn
(14) Outcome: AESD or not
Management information
Registered date
| 2020 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046389
