Journal Article

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

van Veen, Liesanne E J, Plötz, Frans B, Achten, Niek B, van Rossum, Annemarie M C, Ista, Erwin, Tramper-Stranders, Gerdien A

2025

Overview

BackgroundSeveral antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.Methods and analysisWe will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.Ethics and disseminationThe Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.Trial registration numberNCT06845332.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Anti-Bacterial Agents - therapeutic use / Antibiotics / Antimicrobial Stewardship - methods / Clinical outcomes / Controlled Before-After Studies / Hospitals / Humans / Infant, Newborn / Infections / Infectious diseases / Interrupted Time Series Analysis / Midwifery / Multicenter Studies as Topic / Neonatal care / Neonatal Sepsis - drug therapy / NEONATOLOGY / Netherlands / Nurses / Obstetrics / Pediatrics / Prospective Studies / Sepsis / Sepsis - drug therapy / Time series