UMIN-CTR Clinical Trial

Basic information
Public title	Association between Kawasaki Disease and Sensorineural Hearing Loss
Acronym	KDHL
Scientific Title	Association between Kawasaki Disease and Sensorineural Hearing Loss
Scientific Title:Acronym	KDHL
Region	Japan

Condition
Condition	Kawasaki Disease
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prevalence of sensorineural hearing loss associated with Kawasaki Disease and the factors related to its onset.
Basic objectives2	Others
Basic objectives -Others	epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the prevalence of sensorineural hearing loss associated with Kawasaki Disease
Key secondary outcomes	association between sensorineural hearing loss and factors in patients with Kawasaki Disease

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	inpatients of Department of General Pediatrics of Tokyo Metropolitan Children's Medical Center(TMCMC) who had a diagnosis of Kawasaki Disease and are received the first treatment at TMCMC.
Key exclusion criteria	patients who had a diagnosis of hearing loss already. patients with congenital infections of cytomegalovirus, lymphocytic choriomeningitis virus, rubella virus, toxoplasma or shyphilis. patients with chromosomal or genetic abnormality. patients who had taken aminoglycoside antibiotics, loop diuretics, platinum-based drugs or thalidomide. patients who refuse to participate in the research on disclosed information about this research. patients who are assessed inadequate for this study by investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Sakakibara
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code	183-8561
Address	2-8-29, Musashidai, Fuchu City, Tokyo
TEL	042-300-5111
Email	hiroshi_sakakibara@tmhp.jp

Public contact
Name of contact person	1st name Nanako Middle name Last name Kawata
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code	183-8561
Address	2-8-29, Musashidai, Fuchu City, Tokyo
TEL	042-300-5111
Homepage URL
Email	nanako_kawata@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	none
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	Tokyo Metropolitan Children's Medical Center
Address	2-8-29, Musashidai, Fuchu-city, Tokyo
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 06 Month 11 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 04 Month 22 Day
Date of IRB	2019 Year 05 Month 07 Day
Anticipated trial start date	2019 Year 05 Month 27 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other

Other related information

design:prospective observational study. patients:inpatients of Department of General Pediatrics of Tokyo Metropolitan Children's Medical Center from the trial start date to May 2020 who meet all of the inclusion criteria and none of the exclusion criteria. survey items:sexuality, age, history of Kawasaki Disease, blood test data, echocardiography data, auditory brainstem response data, and clinical course of Kawasaki Disease.

Management information
Registered date	2019 Year 06 Month 10 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042071