Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Neonates born at 34 weeks of gestation or later
- Age 0 to 3 days old
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
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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