UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050902 |
|---|---|
| Receipt number | R000058012 |
| Scientific Title | Functional prognostic factors in ICU-intensive pediatric patients: a single-center retrospective study |
| Date of disclosure of the study information | 2023/04/21 |
| Last modified on | 2023/04/21 15:49:49 |
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Basic information
Public title
Functional prognostic factors in ICU-intensive pediatric patients: a single-center retrospective study
Acronym
Functional prognostic factors in ICU-intensive pediatric patients: a single-center retrospective study
Scientific Title
Functional prognostic factors in ICU-intensive pediatric patients: a single-center retrospective study
Scientific Title:Acronym
Functional prognostic factors in ICU-intensive pediatric patients: a single-center retrospective study
Region
| Japan |
Condition
Condition
Children under 16 years old at the time of ICU admission who entered the Shiga University Hospital ICU for therapeutic purposes on or after January 1, 2018 and were discharged by December 31, 2022.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the relationship between factors such as the child's condition and background at ICU admission and the child's condition at discharge or transfer, and analyzes and examines whether the child's vital signs, condition, and background at ICU admission are predictors of functional prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Multiple logistic analysis on how much the following explanatory variables affect the objective variable.
-Objective variables: survival, death discharge
Explanatory variables: information on background and treatment
-Objective variables: home discharge, institutional transfer
Explanatory variables: information on background and treatment
-Objective variable: No medical care initiation required for home discharge, additional medical care initiation required for home discharge
Explanatory variables: information on background and treatment
-Objective variable: No medical care initiation required for institutional transfer, additional medical care initiation required for institutional transfer
Explanatory variables: information on background and treatment
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
| 1 | days-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Age at ICU admission 0 years and older, under 16 years
-Children whose admission to the ICU is for therapeutic purposes
-In case of multiple ICU admissions during one hospitalization, only the first admission is covered
Key exclusion criteria
-Children whose purpose of ICU admission is a procedure (dialysis, central venous catheter insertion, etc.)
-Children who have requested to stop the use of their medical information for research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2111
hqeiyok@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2111
Homepage URL
hqeiyok@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Ethics Review Committee of Shiga University of Medical Science
Address
Seta-Tsukinowa, Otsu
Tel
077-548-2111
hqrec@belle.shiga-med.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
| 2023 | Year | 04 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058012
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
