UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021566 |
|---|---|
| Receipt number | R000024866 |
| Scientific Title | Respiratory Pathogen among Children Who Have Respiratory Failure in Intensive Care Unit Detected By Real Time Polymerase Chain Reaction |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/09/26 14:10:10 |
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Basic information
Public title
Respiratory Pathogen among Children Who Have Respiratory Failure in Intensive Care Unit Detected By Real Time Polymerase Chain Reaction
Acronym
Respiratory Pathogen among Pediatric Respiratory Failure Patients
Scientific Title
Respiratory Pathogen among Children Who Have Respiratory Failure in Intensive Care Unit Detected By Real Time Polymerase Chain Reaction
Scientific Title:Acronym
Respiratory Pathogen among Pediatric Respiratory Failure Patients
Region
| Japan |
Condition
Condition
pediatric respiratory failure patients
Classification by specialty
| Medicine in general | Infectious disease | Pediatrics |
| Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal respiratoy pathogen among children who have respiratory failure at intensive care unit in Japan
Basic objectives2
Others
Basic objectives -Others
To know how the results of pathogen detection change their clinical management
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To reveal respiratoy pathogen among children who have respiratory failure at intensive care unit in Japan
Key secondary outcomes
To know how the results of pathogen detection change their clinical management
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
| 0 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who admitted Tokyo Metropolitan Children's Medical Center or Tokyo Metropolitan Bokutou Hospital during study period
2. Patients who needed to intensive care
the definition of necessity of intensive care
a). Patients who needed mechanical ventilation (including non invasive positive pressure ventilation)
B). needed to transfer an intensive care unit
c). Attending physician think to be needed intensive care
Key exclusion criteria
1. Patients who have difficulty to obtain specimens
2. Patients who don't get informed consent
3. Patients who a researcher think inappropriate as a subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuho Horikoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Infectious Diseases
Zip code
Address
2-8-29 Musashi-dai Fuchu-city, Tokyo, Japan
TEL
+81423005111
yuho_horikoshi@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Ito |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Infectious Diseases
Zip code
Address
2-8-29 Musashi-dai Fuchu-city, Tokyo, Japan
TEL
+81423005111
Homepage URL
http://www.byouin.metro.tokyo.jp/shouni/tiken/koukaigenkou/27b_5doctor.pdf
kenta_ito@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Goverment
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都立小児総合医療センター（東京都）
東京都墨東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
data collection from electronic medical record
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024866
| 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 |
