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

NCT06845332 | Recruiting

• 1 other identifier: T 110
• Study Type: observational
• Target: 55,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Early-onset Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Days on therapy

  12 months pre-implementation and 12 months post-implementation

Study Arms (2)

Pre-implementation cohort

Post-implementation cohort

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The target population neonates with a minimum postmenstrual age of 34 weeks, between 0-3 days old

You may qualify if:

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

You may not qualify if:

• stillborn neonates

Sponsors & Collaborators

• Franciscus Gasthuis: lead

Study Sites (11)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

RECRUITING

Gelre Ziekenhuis

Apeldoorn, Netherlands

RECRUITING

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Treant Ziekenhuis

Emmen, Netherlands

RECRUITING

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

RECRUITING

Tjongerschans Ziekenhuis

Heerenveen, Netherlands

RECRUITING

Zuyderland Medisch

Heerlen, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Antonius Ziekenhuis Sneek

Sneek, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 31479103 BACKGROUND

• 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.

  PMID: 36088952 BACKGROUND

• 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.

  PMID: 28711318 BACKGROUND

• van Veen LEJ, Tramper-Stranders GA, Achten NB, Plotz FB, van Rossum AMC, Ista E. Implementation strategy for an antibiotic stewardship bundle to promote optimal treatment choices in neonates with suspected early-onset sepsis (Protect-Neo): a study protocol for a multicentre, prospective interrupted time series and before-after study. BMJ Open. 2025 Nov 4;15(11):e103368. doi: 10.1136/bmjopen-2025-103368.

  PMID: 41193205 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liesanne E. J. Van Veen, MD

CONTACT

+31628138839

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 25, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (11)