UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054284 |
|---|---|
| Receipt number | R000061995 |
| Scientific Title | Association between delivery type and Kawasaki disease onset |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2024/04/30 03:34:32 |
* 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
Association between delivery type and Kawasaki disease onset
Acronym
Association between delivery type and Kawasaki disease onset
Scientific Title
Association between delivery type and Kawasaki disease onset
Scientific Title:Acronym
Association between delivery type and Kawasaki disease onset
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Kawasaki disease (KD) is an acute systemic vasculitis that primarily affects children in developed countries and often leads to acquired heart disease. KD onset has been suggested to be associated with infections and various environmental factors. However, research on whether the delivery type plays a role in KD development is limited. This study investigated whether cesarean section (CS) or vaginal delivery (VD) is associated with KD onset using a large administrative claims database in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients with KD were identified from the source population. Subsequently, in every case, we randomly selected controls with no KD history based on a risk-set sampling technique. Each patient was matched to four controls of the same sex, age, and registration time in the database. We subsequently examined the association between the delivery type and KD onset using multivariate conditional logistic regression analysis.We defined the primary outcome as KD, based on specific criteria.
Key secondary outcomes
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
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Information on the children delivered via CS or VD and their mothers was collected from all periods in the database. CS was performed using a procedure detected using Japanese medical procedure codes.Herein, the primary outcome was defined as KD occurrence based on specific criteria. Specifically, we included patients diagnosed with KD (ICD-10 code M303) who had received intravenous immunoglobulin treatment.
Key exclusion criteria
Cases labeled as suspected were excluded, whereas those with atypical KD were included. Considering the importance of an accurate diagnosis in this study, we excluded patients more than 6 years of age because this is not the typical age of KD onset, and distinguishing KD from other diseases in this age group is challenging.
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health universty
Division name
Pediatrics
Zip code
4701192
Address
1 98 Dengakugakubo kutsukake Toyoake Aichi
TEL
09025786815
takanori-s@axel.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita health university
Division name
Pediatrics
Zip code
470
Address
1-98 Dengakugakubo kutsukake Toyoake Aichi
TEL
09025786815
Homepage URL
takanori-s@axel.ocn.ne.jp
Sponsor or person
Institute
Chiba Cancer Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
Chiba Cancer Center Research Institute
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Cancer Center Research Institute
Address
666-2 Nitona-cho, Chuo-ku, Chiba 260-8717, Japan
Tel
043-264-5431
nmichihata@chiba-cc.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
| 2024 | Year | 04 | Month | 30 | 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
326867
Results
Of the 326,867 deliveries, 67,098 were identified as CS. The proportions of CS, maternal age, Charlson Comorbidity Index, presence of siblings, and low birth weight infants were significantly different between the cases and controls. In the multivariate analysis, KD onset was associated with CS, the presence of siblings , and lower birth weight.
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The risk of developing KD may be influenced by the delivery type (CS or VD), low birth weight, and the presence of siblings.
Management information
Registered date
| 2024 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061995
