UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029077 |
|---|---|
| Receipt number | R000033258 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2017/09/10 |
| Last modified on | 2017/09/10 21:33:00 |
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Basic information
Public title
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
Acronym
Risk factors for peripherally inserted central catheters associated blood stream infection in Japanese neonatal intensive care units
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Daisuke Kinoshita |
Organization
Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Division name
Neonatology
Zip code
Address
15-749 Honmachi, Higashiyama-ku, Kyoto city, Kyoto 605-0981, Japan
TEL
075-561-1121
daisukekinoshita04@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kinoshita |
Organization
Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Division name
Neonatology
Zip code
Address
15-749 Honmachi, Higashiyama-ku, Kyoto city, Kyoto 605-0981, Japan
TEL
075-561-1121
Homepage URL
daisukekinoshita04@gmail.com
Sponsor or person
Institute
Neonatal Infection Control and Prevention Searching Group in Japan
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 18 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033258
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
