UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028272 |
|---|---|
| Receipt number | R000032366 |
| Scientific Title | Study to establish the safety of using antipyretics with febrile seizures and assess whether acetaminophen could reduce the recurrent risk of febrile seizure in the same fever episode. |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/10/09 13:08:46 |
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Basic information
Public title
Study to establish the safety of using antipyretics with febrile seizures and assess whether acetaminophen could reduce the recurrent risk of febrile seizure in the same fever episode.
Acronym
AAA study
Scientific Title
Study to establish the safety of using antipyretics with febrile seizures and assess whether acetaminophen could reduce the recurrent risk of febrile seizure in the same fever episode.
Scientific Title:Acronym
AAA study
Region
| Japan |
Condition
Condition
febrile seizure
Classification by specialty
| Medicine in general | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish the safety of using antipyretics with febrile seizures and assess whether acetaminophen could reduce the recurrent risk of febrile seizure in the same fever episode.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome is the recurrece of febrile seizure in the same fever episode.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
rectal acetaminophen (10mg/ kg) every 6 hours until 24 hours after the onset of febrile seizure
Interventions/Control_2
without any other antipyretic 24 hours after febrile seizure
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
| 72 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Children and infants who come to emergency room of Hirakata City Hospital with febrile seizures between May 1, 2015, and April 30, 2018, were considered for inclusion in the study.
Key exclusion criteria
1)Patients with seizure over 15 minutes were excluded from the study as status epilepticus.
2)Patients with diarrhea were excluded because it is difficult to put suppositories and other pathologies may be involved such as convulsion with mild gastroenteritis .
3)Patients with epilepsy, chromosomal abnormality, inherited metabolic diseases, brain tumor, cerebral hemorrhage, hydrocephalus, and those with a history of intracranial surgery were excluded.
4)Patients who were used to prevent febrile seizuress with diazepam suppository were excluded.
5)Patients take antihistamine that may increase seizure susceptibility in patients with febrile seizures were also excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Murata |
Organization
Hirakata City Hospital
Division name
Department of Pediatrics
Zip code
Address
2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan
TEL
+81-72-847-2821
wildwind1980@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Murata |
Organization
Hirakata City Hospital
Division name
Department of Pediatrics
Zip code
Address
2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan
TEL
+81-72-847-2821
Homepage URL
wildwind1980@live.jp
Sponsor or person
Institute
Department of Pediatrics, Hirakata City Hospital
2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan
Tel: +81-72-847-2821; Fax: +81-72-847-2825
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Hirakata City Hospital
2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan
Tel: +81-72-847-2821; Fax: +81-72-847-2825
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 30 | Day |
Other
Other related information
Pediatrics Oct 2018, e20181009; DOI: 10.1542/peds.2018-1009
Management information
Registered date
| 2017 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032366
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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