UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037019 |
|---|---|
| Receipt number | R000042071 |
| Scientific Title | Association between Kawasaki Disease and Sensorineural Hearing Loss |
| Date of disclosure of the study information | 2019/06/11 |
| Last modified on | 2022/12/12 09:28:11 |
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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
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
nanako_kawata@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042071
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
