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Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis (PrOTeCt-NEO)

F

Franciscus Gasthuis

Status

Enrolling

Conditions

Early-onset Sepsis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

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.

Enrollment

55,000 estimated patients

Sex

All

Ages

Under 3 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Neonates born at 34 weeks of gestation or later
  • 0-3 days old

Exclusion criteria

  • stillborn neonates

Trial design

55,000 participants in 2 patient groups

Pre-implementation cohort
Post-implementation cohort

Trial contacts and locations

11

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Central trial contact

Liesanne E. J. Van Veen, MD

Data sourced from clinicaltrials.gov

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