UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036995 |
|---|---|
| Receipt number | 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 | 2021/03/08 17:50:06 |
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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
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
miki_tanaka@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042128
