Clinical Research Studies

Despite modern advances that have greatly improved the health outcomes for infants, the field of neonatology still lacks reliable prognostic tools for many disorders. Non-invasively-obtained samples (such as saliva) contains a wealth of biologic information in the form of DNA, RNA, proteins, and metabolites that can predict neonatal outcomes. Exosomes are small, membrane-bound extracellular vesicles (EVs) that are released by a variety of cells and involved in several cell-to-cell communication pathways. A proposed mechanism by which exosomes mediate cell signaling is via microRNAs (miRNAs), which are small, non-coding RNA segments that silence complementary messenger RNA (mRNA) segments. While exosomes have been characterized in biofluids from adults, few studies have examined the diagnostic value of these biofluid exosomes. The objective of this study is to determine whether exosomes can be isolated from full-term neonatal saliva samples, and if so, whether specific biomarkers (such as exosomal miRNAs) can be further characterized. This is significant because findings could suggest ways to measure biomarkers non-invasively in neonates. This exploratory, prospective study will be conducted with samples collected from the NYU Langone – Long Island Outpatient Pediatric Clinic. Specifically, we will measure biomarkers from non-invasive samples (saliva) in full-term infants >37 weeks gestation (n=40) who were never admitted to the Neonatal Intensive Care Unit. Neonates can be enrolled in the first week of life at their first well-baby visit to the Pediatric Clinic. Samples will then be collected at every routine well-baby visit starting in the 2nd week for the first 4 weeks of life. Mouth suctioning to collect saliva samples will be performed specifically for research. All samples will be transported to the PI’s laboratory and processed for experimentation. The biomarkers examined in the lab will then be correlated to neonatal clinical outcomes obtained via medical record review.