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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036995
Receipt No. R000042128
Scientific Title A prospective observational study evaluating febrile seizure recurrence within the same febrile episode
Date of disclosure of the study information 2019/07/01
Last modified on 2019/09/15

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Basic information
Public title A prospective observational study evaluating febrile seizure recurrence within the same febrile episode
Acronym A prospective observational study evaluating febrile seizure recurrence within the same febrile episode
Scientific Title A prospective observational study evaluating febrile seizure recurrence within the same febrile episode
Scientific Title:Acronym A prospective observational study evaluating febrile seizure recurrence within the same febrile episode
Region
Japan

Condition
Condition Febrile seizure
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the recurrence rate of febrile seizures within a single febrile episode in children presenting to the emergency department with the diagnosis of febrile seizure. The difference in the recurrence rate between those receiving diazepam plus acetaminophen (Group 1) and those receiving acetaminophen only (Group 2) will also be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The recurrence rate of seizures within a febrile episode
Key secondary outcomes -recurrence of seizure in each group
-incidence of adverse events in each group
-incidence of central nervous system infection
-frequency of ambulance dispatches due to seizure recurrence in each group
-medical costs in each group

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
6 months-old <=
Age-upper limit
60 months-old >
Gender Male and Female
Key inclusion criteria 1. generalised convulsive seizure
2. spontaneous termination of seizure within 15 minutes
3. axillary temperature 38.0 degrees celsius or higher at presentation
4. no neurological abnormality
5. oral consent obtained from guardians
Key exclusion criteria 1. history of epilepsy, multiple congenital anomalies, including chromosomal disorders, brain tumor, hydrocephalus, congenital metabolic disorder, hypoxic ischemic encephalopathy
2. anticonvulsant administration prior to the consultation
3. two or more seizures during the current fever episode
4. Intraveneous, intranasal or buccal administration of anticonvulsant at the emergency department
5. patients considered ineligible by study members
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Suzuki
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code 183-8561
Address 2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Email satoko_suzuki@tmhp.jp

Public contact
Name of contact person
1st name Miki
Middle name
Last name Tanaka
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code 183-8561
Address 2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Homepage URL http://www.byouin.metro.tokyo.jp/shouni/section/rinshoukenkyu_a_03.html
Email miki_tanaka@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Tokyo Metropolitan Children's Medical Center
Address 2-8-29, Musashidai, Fuchu, Tokyo, Japan
Tel 042-300-5111
Email sn_rinri@tmhp.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
2019 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 Enrolling by invitation
Date of protocol fixation
2019 Year 06 Month 25 Day
Date of IRB
2019 Year 07 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 04 Month 30 Day
Date trial data considered complete
2021 Year 09 Month 30 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information Not applicable

Management information
Registered date
2019 Year 06 Month 07 Day
Last modified on
2019 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042128

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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