Taurolidine Lock for Prevention of Central-Line Associated Bloodstream Infections in Neonates: A Triple-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 576
- Locations
- 1
Study Overview
Brief 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).
Detailed Description
BACKGROUND
The diagnosis of sepsis remains, to this day, one of the most unfavorable for infants admitted to Neonatal Intensive Care Units (NICUs). Neonatal sepsis is classified as: early onset, when it occurs within 48-72 hours of life - typically due to vertical transmission; and late onset, when it occurs beyond 72 hours of life - presumably due to horizontal transmission.
Late-onset sepsis currently affects a clinically significant proportion of neonates, with rates exceeding 10% even in high-income countries, and is characterized by mortality rates reaching up to 35% in the most vulnerable patients, thus representing a major public health concern.
In 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) and CLABSI (Central Line-Associated Bloodstream Infection).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 120 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •presence of a CVC (ECC, CICC, or FICC) for at least 48 hours
- •absence of systemic antibiotic therapy in the 48 hours preceding enrollment
Exclusion Criteria
- •presence of an umbilical venous catheter
- •suspected thrombophilic disorder