UMIN-CTR Clinical Trial

Basic information
Public title	Physical Restraints in Critically Ill Children: Multicenter Longitudinal Point Prevalence Study
Acronym	PRINCE Study
Scientific Title	Physical Restraints in Critically Ill Children: Multicenter Longitudinal Point Prevalence Study
Scientific Title:Acronym	PRINCE Study
Region	Japan

Condition
Condition	critically ill or injured children
Classification by specialty	Pediatrics Intensive care medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the prevalence of and associated factors with physical restraints in critically ill children in Japan.
Basic objectives2	Others
Basic objectives -Others	To explore the prevalence of and associated factors with physical restraints in critically ill children in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence and the characteristics of the physically restrained critically ill or injured children.
Key secondary outcomes	Factors associated with physical restraints.

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 months-old <=
Age-upper limit	120 months-old >
Gender	Male and Female
Key inclusion criteria	Aged 1 month to 10-years-old children in ICUs.
Key exclusion criteria	1) over 10-year-old children 2) newborn 3) without consent
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Ikebe
Organization	Osaka Womens and Childrens Hospital
Division name	Department of Nursing
Zip code	594-1101
Address	840, Murodocyo, Izumi, Osaka
TEL	0725-56-1220
Email	rikebe@wch.opho.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Ikebe
Organization	Osaka Womens and Childrens Hospital
Division name	Department of Nursing
Zip code	594-1101
Address	840, Murodocyo, Izumi, Osaka
TEL	0725-56-1220
Homepage URL
Email	rikebe@wch.opho.jp

Sponsor
Institute	Osaka Womens and Childrens Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Review Board of Osaka Womens and Childrens Hospital
Address	840, Murodocyo, Izumi, Osaka
Tel	0725-56-1220
Email	rikebe@wch.opho.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	2020 Year 05 Month 30 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	398
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	2018 Year 10 Month 20 Day
Date of IRB	2018 Year 11 Month 30 Day
Anticipated trial start date	2019 Year 03 Month 04 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter longitudinal point prevalence study

Management information
Registered date	2020 Year 05 Month 30 Day
Last modified on	2020 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046323