UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044885 |
|---|---|
| Receipt number | R000051264 |
| Scientific Title | Survey of urine collection methods |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/01/16 09:23:06 |
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Basic information
Public title
Practice of urine collection methods for children in pediatric medical facilities
Acronym
Practice of urine collection methods for children in pediatric medical facilities
Scientific Title
Survey of urine collection methods
Scientific Title:Acronym
Survey of urine collection methods
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the method of collecting urine from newborns to 3 years old or younger in pediatric medical facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
How to collect urine for children
Successful collection of urine in children
Ingenuity of collecting urine for children
What to do when a nurse fails to collect urine for a child
Effect on infants when collecting urine
Thoughts of a nurse collecting urine from a child
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses with experience in collecting urine from very low birth weight infants to children under 3 years old
Key exclusion criteria
Nurse who can't speak Japanese
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533985
ykanazawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533985
Homepage URL
ykanazawa@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba
Address
Faculty of Medicine
Tel
02898533985
ykanazawa@md.tsukuba.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 | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
308
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
we need time to analyze.
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
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The urine of a child who has not yet urged to urinate is collected using a urine collection bag. In particular, very low birth weight infants are required to have a weekly urine test for two months. However, collecting urine from a child who does not want to urinate places a heavy burden on the nurse who uses the urine collection bag and the child who uses it. The urine collection bag has been used without any improvement by the fine ingenuity of the nurse. Therefore, we would like to clarify the actual situation of urine collection in order to improve the urine collection method.
Management information
Registered date
| 2021 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051264
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
