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Newborn infection shield: taurolidine lock tested in 576 babies

NCT ID NCT07585188

Prevention Sponsor: University of Turin, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a taurolidine lock solution, placed inside central catheters, can prevent bloodstream infections in newborns. About 576 infants with central lines will receive either the taurolidine lock or a saline lock every 48 hours. The goal is to see if this approach reduces infection rates without causing catheter blockages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
taurolidine 2% lock solution
What this could lead to
If it works, this could provide a safe way to prevent dangerous bloodstream infections in vulnerable newborns with central lines.
What could go wrong
This is an early-stage trial with no results yet. The lock solution may not reduce infections and could cause catheter blockages in very small catheters.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 120 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hyperphagia neonatal sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clabsi - central line associated bloodstream infection Crbsi - catheter related bloodstream infection Neonatal sepsis, late-onset

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sant'Anna Hospital, University of Turin

    Turin, 10126, Italy

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