Neonatal Catheter Lock for Infection Prevention

Summary

For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications and parenteral nutrition in this patient population. From a nosological perspective, sepsis associated with the presence of a venous catheter is defined by two acronyms: CRBSI (Catheter-Related Bloodstream Infection - a microbiological definition) and CLABSI (Central Line-Associated Bloodstream Infection - an epidemiological definition).

Among preventive strategies for CRBSI/CLABSI, antibiotic or antimicrobial catheter lock solutions - instilled in a volume equivalent to the catheter dead space and retained within the lumen until the next use - have demonstrated favorable efficacy in reducing infection risk.

Taurolidine 2% is considered a preferred agent due to its broad-spectrum antibacterial and antifungal activity and its lack of association with the development of antimicrobial resistance.

However, its prophylactic use in neonates remains largely investigational, with current evidence limited to small, retrospective observational studies involving catheters ≥3 Fr (e.g., femoral inserted central catheters - FICCs, centrally inserted central catheters - CICCs, and umbilical venous catheters).

In NICUs, epicutaneo-caval catheters (ECCs) are the most commonly used central venous access devices and represent a major source of catheter-related infections. Despite this, the use of antimicrobial lock prophylaxis in ECCs has been limited by concerns regarding catheter occlusion, given their smaller diameter (≤2 Fr). Nevertheless, available evidence indicates that short-duration locks, when combined with meticulous infusion line management, can be safely implemented without increasing the risk of catheter occlusion.

The aim of the study is to evaluate the efficacy of 2% taurolidine lock in the prevention of CLABSI/CRBSI in neonates with CVC (ECC, FICC, or CICC).

Conditions

• CLABSI - Central Line Associated Bloodstream Infection
• CRBSI - Catheter Related Bloodstream Infection
• Neonatal Sepsis, Late-Onset

Interventions

DEVICE

Taurolidine 2% lock

Lock with a 2% taurolidine solution for a duration of 30 minutes every 48 hours, from CVC insertion until its removal, performed in newborns with epicutaneo-caval catheters (ECCs), femoral inserted central catheters (FICCs), or centrally inserted central catheters (CICCs).

OTHER

Normal saline lock

Lock with normal saline for a duration of 30 minutes every 48 hours, from CVC insertion until its removal, performed in newborns with epicutaneo-caval catheters (ECCs), femoral inserted central catheters (FICCs), or centrally inserted central catheters (CICCs).

Sponsors & Collaborators

• University of Turin, Italy

  lead OTHER

Principal Investigators

• Elena Maggiora, MD · University of Turin, Italy

• Francesco Cresi, MD PhD · University of Turin, Italy

• Giulia Maiocco, MD · University of Turin, Italy

• Alessandra Coscia, MD PhD · University of Turin, Italy

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

120 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2029-10-31

Completion

2029-10-31

Countries

• Italy

Study Locations