Actively Recruiting

Age: 0 - 3Days
All Genders
NCT06845332

Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis

Led by Franciscus Gasthuis · Updated on 2025-09-19

55000

Participants Needed

11

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral switch therapy. These strategies have been proven to be effective and safe and are already applied in several Dutch hospitals. However, this is not the case for all hospitals, leading to significant variations in clinical practice. To facilitate the translation of evidence into practice, active implementation will take place. The primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. The aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the EOS calculator, PCT-guided therapy and iv-to-oral switch therapy) in Dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies. A combination of qualitative and quantitative research methods will be used to assess outcomes. Quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the Business Intelligence units of participating hospitals and anonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.

CONDITIONS

Official Title

Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis

Who Can Participate

Age: 0 - 3Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates born at 34 weeks of gestation or later
  • Age 0 to 3 days old
Not Eligible

You will not qualify if you...

  • Stillborn neonates

AI-Screening

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Trial Site Locations

Total: 11 locations

1

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Actively Recruiting

2

Gelre Ziekenhuis

Apeldoorn, Netherlands

Actively Recruiting

3

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Actively Recruiting

4

Catharina Ziekenhuis

Eindhoven, Netherlands

Actively Recruiting

5

Treant Ziekenhuis

Emmen, Netherlands

Actively Recruiting

6

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Actively Recruiting

7

Tjongerschans Ziekenhuis

Heerenveen, Netherlands

Actively Recruiting

8

Zuyderland Medisch

Heerlen, Netherlands

Actively Recruiting

9

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Actively Recruiting

10

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Actively Recruiting

11

Antonius Ziekenhuis Sneek

Sneek, Netherlands

Actively Recruiting

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Research Team

L

Liesanne E. J. Van Veen, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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