UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of risk factors for peripherally inserted central catheters associated blood stream infection in neonates with birth weight less than or equal to 1,500g: a prospective multicenter observational study in Japanese neonatal intensive care units
Title of the study (Brief title)	Risk factors for peripherally inserted central catheters associated blood stream infection in Japanese neonatal intensive care units
Region	Japan

Condition
Condition	Central catheters associated blood stream infection
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the risk factors of peripherally inserted central catheters associated blood stream infection in neonate with birth weight less than or equal to 1,500g by assessing the effectiveness of clinical prevention practices
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of peripherally inserted central catheters associated laboratory confirmed bloodstream infection and clinical sepsis.
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	0 days-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Neonates born after 22 weeks of gestational age, with birth weight less than or equal to 1,500g. 2) Neonates with their first peripherally inserted central catheters that terminate in the great vessels.
Key exclusion criteria	1) Neonates who were transferred with peripherally inserted central catheters. 2) Still birth or death within 24 hours from birth.
Target sample size	2000

Research contact person
Name of lead principal investigator	Daisuke Kinoshita
Organization	Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Division name	Neonatology
Address	15-749 Honmachi, Higashiyama-ku, Kyoto city, Kyoto 605-0981, Japan
TEL	075-561-1121
Email	daisukekinoshita04@gmail.com

Public contact
Name of contact person	Daisuke Kinoshita
Organization	Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Division name	Neonatology
Address	15-749 Honmachi, Higashiyama-ku, Kyoto city, Kyoto 605-0981, Japan
TEL	075-561-1121
Homepage URL
Email	daisukekinoshita04@gmail.com

Sponsor
Institute	Neonatal Infection Control and Prevention Searching Group in Japan
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 09 Month 10 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 18 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 07 Month 31 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The degree of the insertion and maintenance infection prevention practices, catheter days, clinical event, patient characteristics

Management information
Registered date	2017 Year 09 Month 10 Day
Last modified on	2017 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033258