UMIN-CTR Clinical Trial

Basic information
Public title	An accutracy of core temperature monitoring system SpotOn in pediatric intensive care patients
Acronym	SpotOn in pediatric intensive care patients
Scientific Title	An accutracy of core temperature monitoring system SpotOn in pediatric intensive care patients
Scientific Title:Acronym	SpotOn in pediatric intensive care patients
Region	Japan

Condition
Condition	pediatric intensive care patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the reliability of SpotOn in pediatric intensive care patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between core temperature measured with SpotOn and rectal temperature
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	Not applicable
Age-upper limit	2 years-old >=
Gender	Male and Female
Key inclusion criteria	critically ill pediatric patients requiring intensive care
Key exclusion criteria	patients with a heating device
Target sample size	30

Research contact person
Name of lead principal investigator	1st name MASAFUMI Middle name Last name IDEI
Organization	Tokyo Women's University Hospital
Division name	Department of Intensive Care Unit
Zip code	1628666
Address	31-1-1204
TEL	09055331052
Email	masafumi203@yahoo.co.jp

Public contact
Name of contact person	1st name MASAFUMI Middle name Last name IDEI
Organization	Tokyo Women's University Hospital
Division name	Department of Intensive Care Unit
Zip code	1628666
Address	31-1-1204
TEL	09055331052
Homepage URL
Email	masafumi203@yahoo.co.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanazawa, Yokohama, Japan
Tel	09055331052
Email	masafumi203@yahoo.co.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	2019 Year 09 Month 26 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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 02 Month 27 Day
Date of IRB	2016 Year 05 Month 12 Day
Anticipated trial start date	2015 Year 02 Month 27 Day
Last follow-up date	2019 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retropspective study

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2019 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=R000043446