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RECRUITINGOBSERVATIONAL

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

PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Neonates born at 34 weeks of gestation or later - 0-3 days old Who Should NOT Join This Trial: - stillborn neonates Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Neonates born at 34 weeks of gestation or later * 0-3 days old Exclusion Criteria: * stillborn neonates

Locations (11)

Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Gelre Ziekenhuis
Apeldoorn, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Treant Ziekenhuis
Emmen, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Tjongerschans Ziekenhuis
Heerenveen, Netherlands
Zuyderland Medisch
Heerlen, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Antonius Ziekenhuis Sneek
Sneek, Netherlands