UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040589 |
|---|---|
| Receipt number | R000046323 |
| Scientific Title | Physical Restraints in Critically Ill Children: Multicenter Longitudinal Point Prevalence Study |
| Date of disclosure of the study information | 2020/05/30 |
| Last modified on | 2020/05/30 04:05:52 |
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Basic information
Public title
Physical Restraints in Critically Ill Children: Multicenter Longitudinal Point Prevalence Study
Acronym
PRINCE Study
Scientific Title
Physical Restraints in Critically Ill Children: Multicenter Longitudinal Point Prevalence Study
Scientific Title:Acronym
PRINCE Study
Region
| Japan |
Condition
Condition
critically ill or injured children
Classification by specialty
| Pediatrics | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the prevalence of and associated factors with physical restraints in critically ill children in Japan.
Basic objectives2
Others
Basic objectives -Others
To explore the prevalence of and associated factors with physical restraints in critically ill children in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence and the characteristics of the physically restrained critically ill or injured children.
Key secondary outcomes
Factors associated with physical restraints.
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
| 1 | months-old | <= |
Age-upper limit
| 120 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 1 month to 10-years-old children in ICUs.
Key exclusion criteria
1) over 10-year-old children
2) newborn
3) without consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Ikebe |
Organization
Osaka Womens and Childrens Hospital
Division name
Department of Nursing
Zip code
594-1101
Address
840, Murodocyo, Izumi, Osaka
TEL
0725-56-1220
rikebe@wch.opho.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ikebe |
Organization
Osaka Womens and Childrens Hospital
Division name
Department of Nursing
Zip code
594-1101
Address
840, Murodocyo, Izumi, Osaka
TEL
0725-56-1220
Homepage URL
rikebe@wch.opho.jp
Sponsor or person
Institute
Osaka Womens and Childrens Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka Womens and Childrens Hospital
Address
840, Murodocyo, Izumi, Osaka
Tel
0725-56-1220
rikebe@wch.opho.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
| 2020 | Year | 05 | 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
398
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
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter longitudinal point prevalence study
Management information
Registered date
| 2020 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046323
