Neonatal Catheter Lock for Infection Prevention

NCT07585188 | Not Yet Recruiting

• 1 other identifier: Neo-CLIP
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Taurolidine; Catheter lock therapy; Epicutaneo-caval catheter; Femoral inserted central catheters; Centrally inserted central catheters; Neonatal Intensive Care Unit; Newborn; Parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• Incidence of CLABSI episodes expressed as events per 1000 catheter-days

  From first catheter lock intervention until removal of all central venous catheters (CVCs), an average of 14 days

Secondary Outcomes (11)

• CRBSI episodes (events/1000 catheter-days)

  From first catheter lock intervention until removal of all CVCs, an average of 14 days

• Lock-related CVC complications (failed aspiration, CVC occlusion) (events/number of locks)

  Immediately after each intervention (catheter lock)

• Technical failures in obtaining blood culture from CVC (events); percentage of successful CVC blood sampling

  Immediately after each attempt to obtain a blood culture from a CVC

• Mortality (events)

  From enrollment until hospital discharge, up to 120 days

• Length of hospital stay (days)

  From enrollment until hospital discharge, up to 120 days

Study Arms (2)

Taurolidine 2% lock

EXPERIMENTAL

Lock with a 2% taurolidine solution for a duration of 30 minutes every 48 hours, from CVC insertion until its removal. The lock will be performed according to the following procedure: 1. infusion of lock solution in an amount equal to the dead space of the infusion line (calculated by summing the dead space of the catheter and all add-on devices present between the catheter hub and the access point to the infusion line); the access point to the infusion line must be as proximal as possible to the catheter. 2. non-use of the infusion line for 30 minutes from the time of lock. 3. aspiration of the lock solution at the end of the 30 minutes. 4. restoration of normal use of the infusion line after flushing with normal saline equal to 2 times the dead space of the infusion line (calculated as described above). In the case of non-blood-returning catheters, step 3 will not be feasible, and the procedure will proceed directly to step 4.

Device: Taurolidine 2% lock

Normal saline (0.9% sodium chloride solution) lock

PLACEBO COMPARATOR

Lock with normal saline for a duration of 30 minutes every 48 hours, from CVC insertion until its removal. The lock will be performed according to the following procedure: 1. infusion of lock solution in an amount equal to the dead space of the infusion line (calculated by summing the dead space of the catheter and all add-on devices present between the catheter hub and the access point to the infusion line); the access point to the infusion line must be as proximal as possible to the catheter. 2. non-use of the infusion line for 30 minutes from the time of lock. 3. aspiration of the lock solution at the end of the 30 minutes. 4. restoration of normal use of the infusion line after flushing with normal saline equal to 2 times the dead space of the infusion line (calculated as described above). In the case of non-blood-returning catheters, step 3 will not be feasible, and the procedure will proceed directly to step 4.

Other: Normal saline lock

Interventions

Taurolidine 2% lock DEVICE

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).

Taurolidine 2% lock

Normal saline lock OTHER

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).

Normal saline (0.9% sodium chloride solution) lock

Eligibility Criteria

• Age: 1 Day - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• presence of a CVC (ECC, CICC, or FICC) for at least 48 hours
• absence of systemic antibiotic therapy in the 48 hours preceding enrollment

You may not qualify if:

• presence of an umbilical venous catheter
• suspected thrombophilic disorder

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Sant'Anna Hospital, University of Turin

Turin, 10126, Italy

Location

Related Publications (3)

• D'Andrea V, Prontera G, Vento G. Feasibility of lock solutions for epicutaneo-caval catheters in neonates: the 'LOOSEN' pilot study. J Hosp Infect. 2025 Oct;164:91-95. doi: 10.1016/j.jhin.2025.07.014. Epub 2025 Aug 11.

  PMID: 40803382 BACKGROUND

• Sun Y, Wan G, Liang L. Taurolidine lock solution for catheter-related bloodstream infections in pediatric patients: A meta-analysis. PLoS One. 2020 Apr 7;15(4):e0231110. doi: 10.1371/journal.pone.0231110. eCollection 2020.

  PMID: 32255798 BACKGROUND

• Savarese I, Yazami S, De Rose DU, Carkeek K, Campi F, Auriti C, Danhaive O, Piersigilli F. Use of 2% taurolidine lock solution for treatment and prevention of catheter-related bloodstream infections in neonates: a feasibility study. J Hosp Infect. 2024 Jan;143:76-81. doi: 10.1016/j.jhin.2023.11.003. Epub 2023 Nov 14.

  PMID: 37972710 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis; Hyperphagia

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Elena Maggiora, MD

  University of Turin, Italy

  STUDY DIRECTOR

• Francesco Cresi, MD PhD

  University of Turin, Italy

  STUDY DIRECTOR

• Giulia Maiocco, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Alessandra Coscia, MD PhD

  University of Turin, Italy

  STUDY CHAIR

Central Study Contacts

Francesco Cresi, MD PhD

CONTACT

+390113135781; francesco.cresi@unito.it

Giulia Maiocco, MD

CONTACT

+390113134437; giulia.maiocco@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)