UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 03 Month 08 Day

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