Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06845332

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • stillborn neonates

Treatment and study plan

Primary outcomes

  1. Days on therapy

    Time frame: 12 months pre-implementation and 12 months post-implementation

Study contacts

Contact information is provided by the study sponsor or research team.

Liesanne E. J. Van Veen, MD

CONTACT

+31628138839

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis

Other

Registry information

Official study title

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

Acronym: PrOTeCt-NEO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.