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

Recruiting

• Conditions: Catheter-related Bloodstream Infection; Preterm; Catheter Infection; Catheter Complications
• Interventions: Combination Product: neutrox

• Registration Number: NCT05729321
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2022-11-05
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-16
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epicutaneo-caval catheter removed electively	neutrox	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.

Primary Outcome Measures

Name	Time	Method
Pressure level mmHg	1 hours	The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.

Trial Locations

Locations (2)

Fondazione Policlinico Gemelli IRCSS; 🇮🇹 Roma, Itsly, Italy

FPGemelliIRCCS; 🇮🇹 Rome, Italy