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New study aims to cut unnecessary antibiotics in newborns

NCT ID NCT06845332

Knowledge-focused Sponsor: Franciscus Gasthuis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study will roll out three proven antibiotic stewardship strategies in Dutch hospitals to see if they reduce unnecessary antibiotic use in newborns with suspected early-onset sepsis. Researchers will compare data from before and after the strategies are put in place, involving up to 55,000 babies born at 34 weeks or later. The goal is to make care more consistent and safer.

What this could mean

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

Active substance
antibiotic stewardship strategies (EOS calculator, procalcitonin-guided therapy, IV-to-oral switch)
What this could lead to
If successful, this could help standardize safe antibiotic use in newborns, reducing unnecessary treatment and hospital stays.
What could go wrong
This is an implementation study, not a test of new drugs. Results may vary across hospitals, and the strategies may not reduce antibiotic use as expected.

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.

Participants

About 55,000 people

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

Started

Jan 2024

Expected to finish

Jun 2026

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.

Who is studied

The target population neonates with a minimum postmenstrual age of 34 weeks, between 0-3 days old

Ages

Up to 3 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: * Neonates born at 34 weeks of gestation or later * 0-3 days old Exclusion Criteria: * stillborn neonates

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

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

Early onset sepsis

How to take part

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

  1. The places running it

    11 sites. 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

  • Admiraal de Ruyter Ziekenhuis

    RECRUITING

    Goes, Netherlands

  • Albert Schweitzer Ziekenhuis

    RECRUITING

    Dordrecht, Netherlands

  • Antonius Ziekenhuis Sneek

    RECRUITING

    Sneek, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, Netherlands

  • Gelre Ziekenhuis

    RECRUITING

    Apeldoorn, Netherlands

  • Medisch Centrum Leeuwarden

    RECRUITING

    Leeuwarden, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, Netherlands

  • Tjongerschans Ziekenhuis

    RECRUITING

    Heerenveen, Netherlands

  • Treant Ziekenhuis

    RECRUITING

    Emmen, Netherlands

  • Zuyderland Medisch

    RECRUITING

    Heerlen, Netherlands

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