Safety and Efficacy of Early-onset Sepsis Risk Calculator Among at-risk for Sepsis Neonates Born at 34 Weeks and Beyond – A Randomized Controlled Trial

Background: Neonatal sepsis continues to be the significant cause of morbidity and mortality in newborns, particularly in low- and middle-income countries (LMICs). Diagnosis of sepsis is challenging due to the non-specific clinical manifestations and is often based on the risk factors and clinical assessment by the treating physicians. This study aimed to evaluate the efficacy of the Early-Onset Sepsis Risk Calculator (EOS-RC) in reducing unnecessary antibiotic usage among at-risk neonates born at 34 weeks of gestation and beyond. Methods: A prospective, randomized control trial was conducted at a tertiary care teaching institution in South India between Feb 2023 and Jan 2024. A total of 180 neonates classified as ‘at risk for sepsis’ were enrolled in the study. Neonates were randomized into two groups: the Sepsis Risk Calculator (SRC) group, which followed the EOS-RC guidelines for management, and the Standard Clinical Guidelines (SCG) group, which received conventional management protocols. The primary outcome measured was the proportion of neonates treated with antibiotics in each group. Secondary outcomes included the number of septic screens performed, blood cultures taken, and the length of hospital stay. Results: The study found that 20.9% of neonates in the SRC group received antibiotics compared to 59.6% in the SCG group ( p < 0.001), indicating a significant reduction in antibiotic use. The number of septic screens performed was reduced by 36% in the SRC group, with a comparable reduction in blood cultures (37% in SRC vs. 69% in SCG, p < 0.05). There was no significant difference in the length of hospital stay between the two groups. Conclusion: The implementation of the EOS-RC effectively reduced unnecessary antibiotic usage in at-risk neonates without compromising patient safety. This study supports the integration of risk calculators in neonatal care to enhance antibiotic stewardship and improve clinical outcomes.