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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018259
Receipt No. R000021123
Scientific Title multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion
Date of disclosure of the study information 2015/07/15
Last modified on 2015/07/09

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Basic information
Public title multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion
Acronym registry-AESD
Scientific Title multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion
Scientific Title:Acronym registry-AESD
Region
Japan

Condition
Condition acute encephalopathy with biphasic seizures and late reduced diffusion (AESD)
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy of current treatments for acute encephalopathy with biphasic seizures and late reduced diffusion (AESD) by multicentric, registry-formed cohort study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes of the rate of patients with score 1 and 2 by Pediatric Cerebral Performance Category Scale (PCPC scale)
Key secondary outcomes surveillance of current therapeutic regimen for AESD

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

Not applicable
Gender Male and Female
Key inclusion criteria patients who presented first and second phase (biphasic) seizures:
1) seizures during febrile (37.5 degrees C or higher) illness (first phase seizures)
2) secondary seizures with 24-hour or longer interval after first phase seizures (second phase seizures)
Key exclusion criteria 1) biphasic seizures induced by the disorders other than AESD, e.g., meningitis/encephalitis caused by pathogenic organism or immunological mechanism, other types of acute encephalopathies, epileptic seizures, disorders by unknown etiology but obviously different from AESD
2) judged as inappropriate for this study by investigators
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohide Goto, Sahoko Miyama
Organization Kanagawa Children's Medical Center, Tokyo Metropolitan Children's Medical Center
Division name Division of Neurology
Zip code
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa232-0066, Japan
TEL 045-711-2351
Email tgoto@kcmc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuri Sakaguchi
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Neurology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo183-8561, Japan
TEL 042-300-5111
Homepage URL
Email sn_AESD@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Hospital Group
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 07 Month 15 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
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information to evaluate the efficacy of current treatments for acute encephalopathy with biphasic seizures and late reduced diffusion (AESD) by multicentric, registry-formed cohort study

Management information
Registered date
2015 Year 07 Month 09 Day
Last modified on
2015 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021123

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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