Antimicrobial stewardship in neonatal intensive care units in resource-limited regions of China: a protocol for a multicenter, before-and-after, interrupted time series quality improvement study.

INTRODUCTION

Antibiotic overuse is prevalent in neonatal intensive care units (NICUs) and is associated with adverse neonatal outcomes and antimicrobial resistance. While antimicrobial stewardship programs (ASPs) have been implemented globally, antibiotic utilization rates remain high in China, particularly in resource-limited regional settings. Evidence indicates that guideline dissemination alone is insufficient to alter established prescribing behaviors, underscoring the need for pragmatic, system-level quality improvement (QI) strategies. This study outlines a multicenter QI initiative designed to optimize antibiotic use in NICUs within a resource-limited region of China.

METHODS

This ongoing study uses a multicenter, before-and-after interrupted time series (ITS) design across five NICUs in the Suqian region. A bundled ASP intervention is being implemented, comprising standardized early-onset sepsis risk stratification, mandatory 48-72-h antibiotic reassessment, protocolized empirical antibiotic regimens, and a two-tier governance structure supported by monthly Plan-Do-Study-Act cycles. Monthly aggregated data are collected during a 12-month baseline period (2025) and a 12-month intervention period (2026-2027). Primary outcomes are the antibiotic use rate and the antibiotic utilization rate (days of therapy per 1,000 patient-days). Balancing measures include the incidence of late-onset sepsis, in-hospital mortality, and antibiotic re-initiation rate. Process adherence is monitored as a key implementation indicator. Segmented regression ITS analysis and statistical process control charts are used to evaluate the intervention effect.

DISCUSSION: This study evaluates a pragmatic, workflow-integrated ASP QI model for regional NICUs with limited resources. By integrating standardized clinical pathways, structured reassessment, and continuous data-driven feedback within a multicenter collaborative framework, the intervention aims to safely reduce unnecessary antibiotic exposure. The findings will provide evidence to inform scalable antimicrobial stewardship strategies in similar resource-constrained neonatal care settings.

CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, dentifier: ChiCTR2600120301.