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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021566
Receipt No. 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

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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
Email 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
Email kenta_ito@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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