UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046458 |
|---|---|
| Receipt number | R000046606 |
| Scientific Title | Evaluation of simple preparation and parental attendance in pediatric MRI |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2024/06/13 09:36:18 |
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Basic information
Public title
Evaluation of simple preparation and parental attendance in pediatric MRI
Acronym
Evaluation of simple preparation and parental attendance in pediatric MRI
Scientific Title
Evaluation of simple preparation and parental attendance in pediatric MRI
Scientific Title:Acronym
Evaluation of simple preparation and parental attendance in pediatric MRI
Region
| Japan |
Condition
Condition
Children aged 4-6 years who may need sedation to take an MRI examination ordered by a pediatrician
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirm that the success rate of non-sedation examination and the non-sedation imaging rate change depending on the implementation of simple preparation and the attendance of parents during the examination in pediatric MRI examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the success rate of non-sedation examination
Key secondary outcomes
the non-sedation imaging rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We perform simple preparation before imaging MRI.
Interventions/Control_2
We don't perform simple preparation before imaging MRI.
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
| 4 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 4 to under 7 who undergo MRI examination ordered by a pediatrician.
Cases that his parents agree to participate the study.
Key exclusion criteria
Cases that the doctor deem it to necessary emergency testing (when the examination appointment date and implementation date are within 24 hours)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8550
Address
65 Tsurumai-chou , shouwa-ku, Nagoya, Japan
TEL
052-744-2309
kawadaj@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kawada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8550
Address
65 Tsurumai-chou , shouwa-ku, Nagoya, Japan
TEL
052-744-2309
Homepage URL
kawadaj@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nagoya university
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
Nagoya University Hospital
Address
65 Tsurumai-chou , shouwa-ku, Nagoya, Japan
Tel
052-744-2309
kawadaj@med.nagoya-u.ac.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
| 2021 | Year | 12 | Month | 24 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046606
