Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study (LOOSEN)

February 14, 2023 updated by: D ANDREA VITO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Epicutaneo-caval catheters (ECCs) are widely used in neonatal intensive care units (NICUs). They are small catheters inserted via superficial veins of the limbs or scalp using direct vein visualization The pathogenic microorganisms colonized inside catheters can easily form a bacterial biofilm and eventually spread with blood flow which causes bloodstream infection. Many authors have studied the antibiotic-lock therapy (ALT) in which a high-dose antibiotic solution is dripped and maintained in the catheter cavity for a certain period and can dissolve the biofilm formed on the wall to reduce the colonization of the bacteria and kill the embedded bacteria.The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • FPGemelliIRCCS
    • Itsly
      • Roma, Itsly, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Gemelli IRCSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All infants who have catheters that need to be removed electively.

Description

Inclusion Criteria:

All the Epicutaneo-caval catheter that need to be removed electively will be included in the study -

Exclusion Criteria:

All the Epicutaneo-caval catheters removed not electively but for infectious or mechanical complications will be excluded from the study.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epicutaneo-caval catheter removed electively
This is a pilot study designed to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour in order to assess the feasibility of possible Taurolidine lock-terapy in Epicutaneo-Caval Catheters.
Combination product: neutrox
Each ECC, after discontinuing the Parental Nutrition (NP) infusion, will be flushed with 0.3 ml saline. Subsequently, Saline will be infused at a rate of 2 ml/h for 10 minutes. The ECC will then be closed for 1 hour. At the end of the hour the ECC will be once again flushed with 0.3 ml Saline and infused with SF at the rate of 2 cc/h for 10 minutes. The difference in pressure of the two infusions, before and after catheter closure, will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure level mmHg
Time Frame: 1 hours
The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.
1 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

November 5, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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