Background: Neonatal early onset sepsis (NEOS) is a serious and potentially life-threatening condition affecting newborns within the first few days of life. While the diagnosis of NEOS was based on clinical signs and symptoms in the past, recent years have seen growing interest in identifying specific diagnostic factors and optimizing therapy outcomes. This study aims to investigate the diagnostic and risk factors and therapy outcomes of neonatal EOS in ICU patients in Saudi Arabia, with the goal of improving the management of neonatal EOS in the country. Methods: This method outlines the protocol development, search strategy, study selection, and data collection process for a systematic review on neonatal early onset sepsis in Saudi Arabian ICU patients, following the PRISMA 2020 guidelines. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is a well-established guideline that provides a framework for conducting systematic reviews and meta-analyses in a transparent and standardized manner. It aims to improve the quality and reporting of such research by ensuring clear and comprehensive reporting of study methods, results, and interpretations. The search strategy included electronic databases (PubMed, Embase, Google Scholar, Science Direct, and the Cochrane Library) and manual search of relevant studies, and data were extracted using a standardized form. Results: The systematic review included 21 studies on neonatal sepsis in Saudi Arabia, with varying study designs, sample sizes, and prevalence rates of sepsis. Group B streptococcus and E. coli were the most commonly isolated pathogens. Various diagnostic factors and risk factors were reported, including hematological parameters, biomarkers, and blood cultures. The quality of the included studies was assessed using the Newcastle-Ottawa Scale and Joanna Briggs Institute critical checklist. Conclusions: The review identified a number of risk and diagnostic factors and therapy outcomes for neonatal sepsis. However, most of the studies were having small scale cohort groups. Further research with controlled study designs is needed to develop effective prevention and management strategies for neonatal sepsis in Saudi Arabia.
