An observational study in Early-onset Sepsis, sponsored by Franciscus Gasthuis. Recruiting at 11 sites in Netherlands. Open to participants aged Up to 3 Days. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Franciscus Gasthuis · Observational
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.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
This study's planned enrollment of 55,000 is above the median of 200 across 85 observational studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →Franciscus Gasthuis is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
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The target population neonates with a minimum postmenstrual age of 34 weeks, between 0-3 days old
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Exclusion Criteria:
Days on therapy
Time frame: 12 months pre-implementation and 12 months post-implementation
Plan to share: No
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Franciscus Gasthuis