Development of a microRNA-based Diagnostic Platform of Biomarker Panel for Neonatal Sepsis Detection

Description :

Neonatal Sepsis (NS) is a life-threatening infection, contributing to substantial mortality and morbidity for newborns globally. Empiric antibiotic therapy for preterm infants, suspected of late-onset sepsis, is the standard of care, pending blood culture results. This leads to the overtreatment of a large majority of patients, an increase in hospital stay, and; thus, a rise in healthcare cost burden. Despite extensive research, there are no specific biomarkers that can be utilized in determining the diagnosis of late-onset sepsis (LOS) among neonates. There is an unmet need in developing a timely and accurate detection kit of late-onset NS markers to direct therapy and reduce unnecessary treatment burden and associated complications. These sepsis-specific biomarker(s) should provide a quick, sensitive and specific response for LOS occurrence, which can be widely detected in biofluids. Of interest, microRNAs (miRNAs) are genetic molecules bound in the living cells which have been indicated in condition of NS. Cell-free miRNAs, in a diseased state, are stable and released in blood and saliva as mechanistic pathophysiology indicators and can be used as a diagnostic marker(s) which can be easily quantified. Our proposal aims to develop an accurate and sensitive diagnostic platform for LOS detection in preterm infants born between 28-32 weeks of gestation, via the identification and validation of a specific miRNA profile panel as a portable assay allowing for rapid clinical setting applications. A successful outcome of this project will help in developing a non-invasive specific diagnostic test for early diagnosis of NS, which will guide in optimal treatment options decreasing the burden on neonates, and the financial cost of hospitalization. Thus, a final output of this proposal is to develop a prototype miRNA-based point of care (POC) diagnostic tool that will help in reducing the sepsis-associated morbidity and lower the cost of care.