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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040202
Receipt No. R000045844
Scientific Title EFFICACY OF CYANACRYLATE IN REDUCING THE MIGRATION OF UMBILICAL VENOUS CATHETERS: A RANDOMIZED CONTROLLED TRIAL
Date of disclosure of the study information 2021/05/31
Last modified on 2020/04/20

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Basic information
Public title EFFICACY OF CYANACRYLATE IN REDUCING THE MIGRATION OF UMBILICAL VENOUS CATHETERS: A RANDOMIZED CONTROLLED TRIAL
Acronym GLUV-TRIAL
Scientific Title EFFICACY OF CYANACRYLATE IN REDUCING THE MIGRATION OF UMBILICAL VENOUS CATHETERS: A RANDOMIZED CONTROLLED TRIAL
Scientific Title:Acronym GLUV-TRIAL
Region
Europe

Condition
Condition Neonatology
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the effectiveness of the fixing of the umbilical venous catheter by combining the cyanoacrylate glue plus the suture point in order to reduce migration compared to fixing with the single suture point.
Basic objectives2 Others
Basic objectives -Others Incidence of catheter-related sepsis
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes percentage of catheter migration 24 hours after placement.
Key secondary outcomes percentage of catheter-related sepsis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 umbilical venous catheter fixation with cyanoacrylate glue plus point of suture
Interventions/Control_2 umbilical venous catheter fixation with point of
suture
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 days-old <=
Age-upper limit
28 days-old >=
Gender Male and Female
Key inclusion criteria need of an umbilical venous catheter
Key exclusion criteria abdominal congenital malformations
Target sample size 128

Research contact person
Name of lead principal investigator
1st name Vito
Middle name
Last name D&#39;Andrea
Organization Fondazione Policlinico Universitario A. Gemelli
Division name Neonatologia
Zip code 00168
Address Largo A. Gemelli, 8
TEL 390630154357
Email vito.dandrea@policlinicogemelli.it

Public contact
Name of contact person
1st name Simonetta
Middle name
Last name Costa
Organization Fondazione Policlinico Universitario A. Gemelli
Division name Neonatologia
Zip code 00168
Address Largo A. Gemelli, 8
TEL 390630154357
Homepage URL
Email simonetta.costa@policlinicogemelli.it

Sponsor
Institute Fondazione Policlinico Universitario A. Gemelli
Institute
Department

Funding Source
Organization Fondazione Policlinico Universitario A. Gemelli
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 Fondazione Policlinico Universitario A. Gemelli
Address Largo A. Gemelli, 8
Tel 39063015.6124
Email comitato.etico@policlinicogemelli.it

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
2021 Year 05 Month 31 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 Open public recruiting
Date of protocol fixation
2020 Year 02 Month 10 Day
Date of IRB
2020 Year 04 Month 02 Day
Anticipated trial start date
2020 Year 04 Month 15 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 20 Day
Last modified on
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045844

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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