Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis
NCT ID: NCT06845332
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
55000 participants
OBSERVATIONAL
2024-01-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Pre-implementation cohort
No interventions assigned to this group
Post-implementation cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 0-3 days old
Exclusion Criteria
3 Days
ALL
No
Sponsors
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Franciscus Gasthuis
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Liesanne E. J. Van Veen, MD
Role: CONTACT
References
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Achten NB, Klingenberg C, Benitz WE, Stocker M, Schlapbach LJ, Giannoni E, Bokelaar R, Driessen GJA, Brodin P, Uthaya S, van Rossum AMC, Plotz FB. Association of Use of the Neonatal Early-Onset Sepsis Calculator With Reduction in Antibiotic Therapy and Safety: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Nov 1;173(11):1032-1040. doi: 10.1001/jamapediatrics.2019.2825.
Keij FM, Kornelisse RF, Hartwig NG, van der Sluijs-Bens J, van Beek RHT, van Driel A, van Rooij LGM, van Dalen-Vink I, Driessen GJA, Kenter S, von Lindern JS, Eijkemans M, Stam-Stigter GM, Qi H, van den Berg MM, Baartmans MGA, van der Meer-Kappelle LH, Meijssen CB, Norbruis OF, Heidema J, van Rossem MC, den Butter PCP, Allegaert K, Reiss IKM, Tramper-Stranders GA. Efficacy and safety of switching from intravenous to oral antibiotics (amoxicillin-clavulanic acid) versus a full course of intravenous antibiotics in neonates with probable bacterial infection (RAIN): a multicentre, randomised, open-label, non-inferiority trial. Lancet Child Adolesc Health. 2022 Nov;6(11):799-809. doi: 10.1016/S2352-4642(22)00245-0. Epub 2022 Sep 9.
Stocker M, van Herk W, El Helou S, Dutta S, Fontana MS, Schuerman FABA, van den Tooren-de Groot RK, Wieringa JW, Janota J, van der Meer-Kappelle LH, Moonen R, Sie SD, de Vries E, Donker AE, Zimmerman U, Schlapbach LJ, de Mol AC, Hoffman-Haringsma A, Roy M, Tomaske M, Kornelisse RF, van Gijsel J, Visser EG, Willemsen SP, van Rossum AMC; NeoPInS Study Group. Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis: a multicentre, randomised controlled trial (NeoPIns). Lancet. 2017 Aug 26;390(10097):871-881. doi: 10.1016/S0140-6736(17)31444-7. Epub 2017 Jul 12.
Other Identifiers
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T 110
Identifier Type: -
Identifier Source: org_study_id
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