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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038908
Receipt No. R000044007
Scientific Title Prospective observational study on child development born to mother with antiepileptic drugs
Date of disclosure of the study information 2020/04/01
Last modified on 2019/12/17

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Basic information
Public title Prospective observational study on child development born to mother with antiepileptic drugs
Acronym Prospective observational study on child development born to mother with antiepileptic drugs(JES-AEDs-CH)
Scientific Title Prospective observational study on child development born to mother with antiepileptic drugs
Scientific Title:Acronym Prospective observational study on child development born to mother with antiepileptic drugs(JES-AEDs-CH)
Region
Japan

Condition
Condition Epilepsy
Classification by specialty
Neurology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the development of children born to mothers who took antiepileptic drugs during pregnancy and to determine the effects of antiepileptic drugs on cognition.
Basic objectives2 Others
Basic objectives -Others To clarify the effects of factors other than antiepileptic drugs on cognitive development
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive development of children exposed to AEDs during fetus
Key secondary outcomes -Safety of breastfeeding while taking antiepileptic drugs
-Influence of seizures during pregnancy upon cognitive development of the child
-Intake of folic acid and its effect on cognitive development
-Relation between antiepileptic drug dose (and its serum concentration) and cognitive development of the child
-Correlation of cognitive status of the child with that of mother

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) Child with parental consent born to mother with epilepsy
(2) The mother must be participating in JES-AEDs-PG.
Key exclusion criteria (1) Those judged as inappropriate for participation in this study by the principal investigator/sub-investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yushi
Middle name
Last name Inoue
Organization National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders
Division name Division of Clinical Research
Zip code 420-8688
Address 886 Urushiyama , Aoi-ku, Shizuoka-shi, Shizuoka, 420-8688, Japan
TEL 054-245-5446
Email yinoue-jes@umin.net

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Ohtani
Organization National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name Division of clinical Research
Zip code 420-8688
Address 886 Urushiyama , Aoi-ku, Shizuoka-shi, Shizuoka, 420-8688, Japan
TEL 054-245-5446
Homepage URL
Email h-ohtani@shizuokamind.org

Sponsor
Institute National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department

Funding Source
Organization JES Pregnancy Registry Fund
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 The Japan Epilepsy Society
Address 4-6-5 Ogawahigashicho, Kodairashi, Tokyo
Tel 042-345-2522
Email jes-oas@umin.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 04 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
2019 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2033 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data will be analyzed relating to the results of JES-AEDs-PG (UMIN000034135)

Management information
Registered date
2019 Year 12 Month 17 Day
Last modified on
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044007

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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