UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028272
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email wildwind1980@live.jp

Sponsor
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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.