UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Shinya Murata
Organization	Hirakata City Hospital
Division name	Department of Pediatrics
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	Shinya Murata
Organization	Hirakata City Hospital
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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