UMIN-CTR Clinical Trial

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