Clinical Research Studies

Despite modern advances that have greatly improved the health outcomes for preterm infants, the field of neonatology still lacks reliable prognostic tools for many disorders. Noninvasively-obtained samples (such as blood, trach aspirate, urine, saliva and stool samples) contain 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 biofluid exosomes. The objective of this study is to determine whether exosomes can be isolated from neonatal blood, urine, trach aspirate, saliva and stool samples, and if so, whether specific biomarkers (such as exosomal miRNAs) are associated with distinct neonatal pathologies such as chronic lung disease of prematurity (BPD: Bronchopulmonary dysplasia) or other neonatal inflammatory conditions. This is significant because findings could revolutionize the way preterm infants in neonatal intensive care units (NICUs) are monitored at the bedside. This exploratory, prospective study will be conducted with samples collected from the NYU Winthrop Hospital NICU. Specifically, we will measure biomarkers from non-invasive samples (Blood, urine, saliva and stool samples) in two groups; 1) preterm infants <37 weeks gestation (n=100) and 2) term infants <37 weeks gestation (n=50). Neonates can be enrolled in the first week of life. Samples will be collected once/week until the baby is discharged home. Saliva (obtained by mouth suctioning), tracheal aspirate (collected from discarded routine tracheal suctioning in intubated babies only), urine (collected in urine bag) and stools (present in diapers) are routinely collected and discarded in the NICU. Sometimes mouth suctioning is not routinely done for all babies. If this to occur, mouth suctioning to collect saliva samples will be performed specifically for research. In addition, blood samples equal to 1 ml (1/5 teaspoon) will be collected per week either from leftover blood work ordered by medical team or if not available, blood will be collected specifically for research (obtained during routine blood drawing ordered by the medical team). The maximum amount of blood taken for this study (if no leftover blood is available) will not exceed 15 ml total throughout the hospital course). 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.