A real-world observational study on antibiotic use, microbiological patterns, and pragmatic stewardship–IPC interventions in a mozambican neonatal unit

Background Neonatal sepsis remains a leading cause of mortality in low- and middle-income countries, where limited diagnostics contribute to empirical antibiotic use and antimicrobial resistance. Data from Mozambique remain scarce. We aimed to describe neonatal sepsis epidemiology, antimicrobial use, and resistance patterns, and assess the impact of integrated antimicrobial stewardship (ASP) and infection prevention and control (IPC) interventions on antibiotic use and mortality. Methods This retrospective before-and-after cohort study used data collected from neonates admitted to the neonatal unit (NU) of Beira Central Hospital, Mozambique, during 2024. Clinical, microbiological, and antibiotic prescribing data were compared before and after ASP/IPC implementation. Primary outcomes were antibiotic use and in-hospital mortality. Monthly mortality trends were assessed by interrupted time series analysis, with modified Poisson regression adjusted for differences in patient characteristics. Findings Among 1856 neonates, 74.4% received antibiotics, and 33.5% had at least one blood culture. Culture positivity increased from 53.8% to 72.6% after targeted sampling criteria were introduced. Gram-negative organisms predominated, particularly Klebsiella spp ., with high resistance to WHO-recommended first-line antibiotics. Crude mortality rose from 28.6% to 33.2%; however, post-intervention mortality declined over time (IRR 0.95, 95% CI 0.91–0.99), while adjusted mortality did not differ between periods (aPR 1.04, 95% CI 0.92–1.18). Interpretation In a high-burden resource-limited NU, integrated ASP and IPC interventions improved diagnostic yield, supported more targeted antibiotic use, and were associated with a declining mortality trend, supporting the feasibility and clinical value of locally adapted ASP and IPC interventions. Funding Italian Agency for Development Cooperation, project PROTECT (AID012590/06/0).