RecruitingNCT06845332

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


Sponsor

Franciscus Gasthuis

Enrollment

55,000 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 3 Days

Inclusion Criteria2

  • Neonates born at 34 weeks of gestation or later
  • -3 days old

Exclusion Criteria1

  • stillborn neonates

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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

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NCT06845332