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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044885
Receipt No. R000051264
Scientific Title Survey of urine collection methods
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/10

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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
Email 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
Email ykanazawa@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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 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 Preinitiation
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
2023 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
2021 Year 11 Month 10 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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