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New device aims to stop deadly infections in tiny preemies

NCT ID NCT02633124

Prevention Sponsor: University Hospital, Lille 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special multi-line device (Edelvaiss Multiline NEO) to see if it could prevent bloodstream infections in very premature infants (24-29 weeks) who need IV medications and nutrition. The device was compared to standard infusion sets. Unfortunately, the trial was stopped early, so we don't have clear answers.

What this could mean

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

Active substance
Edelvaiss Multiline NEO device
What this could lead to
If proven effective, this device could reduce dangerous bloodstream infections in premature babies, shortening hospital stays and saving lives.
What could go wrong
The trial was terminated early with only 87 participants, so we don't have enough data to know if the device works. It may not be better than standard care.

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

87 people

The number who actually took part.

Started

Jan 2016

Finished

May 2020

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

24 to 29 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Infants with gestational ages between 24 and 29 weeks. * Infants carrying a single-lumen central venous catheter. * Obtaining the informed parental consent. Exclusion Criteria: * Infants carrying a multi-lumen central venous catheter. * Infants carrying a umbilical venous catheter. * Infants carrying two central venous catheters. * Refusal of informed parental consent.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis Premature Birth

As listed by the trial registrant

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

Bacteremia Infant, very low birth weight

Contacts and locations

Locations

  • Chu Amiens Picardie

    Amiens, France

  • Hôpital Charles Nicolle - CHU de Rouen

    Rouen, France

  • Hôpital Côte de Nacre - CHU de Caen

    Caen, France

  • Hôpital Jeanne de Flandre - CHRU de Lille

    Lille, France

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