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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06845332
Acronym
PrOTeCt-NEO
Enrollment
55000
Registered
2025-02-25
Start date
2024-01-01
Completion date
2026-06-01
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-onset Sepsis

Keywords

early-onset sepsis, neonatal sepsis, early-onset sepsis calculator, PCT-guided therapy, iv-to-oral switch therapy, implementation

Brief 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.

Interventions

None listed

Sponsors

Franciscus Gasthuis
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* stillborn neonates

Design outcomes

Primary

MeasureTime frame
Days on therapy12 months pre-implementation and 12 months post-implementation

Countries

Netherlands

Contacts

Primary ContactLiesanne E. J. Van Veen, MD
+31628138839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026