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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040644
Receipt No. 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 2020/06/03

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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
Email 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
Email matsuo@cc.saga-u.ac.jp

Sponsor
Institute Saga University, Faculty of Medicine
Institute
Department

Funding Source
Organization Saga University, Faculty of Medicine
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 the institutional review board of Saga University Hospital
Address 5-1-1 Nabeshima, Saga
Tel 0952242314
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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