Annually, more than one million pediatric patients require enteral nutrition (EN) in the U.S. For patients in the neonatal intensive care unit (NICU), providing nutrition is especially critical to ensuring that proper growth and development occur. While EN is life-saving, feeding tubes (FTs) have seen limited innovation in recent years, even though they can be a source of complications. Today, FTs are placed blindly at the bedside in the NICU. FT misplacement into the duodenum, esophagus, and lungs is associated with complications that can lead to prolonged hospital stays, morbidity, and, in rare cases, mortality. Each NICU relies on a combination of methods for placement confirmation, which include FT insertion length, auscultation, capnography, and aspiration of gastric residuals. Each method has limitations, resulting in high misplacement rate overall (4-59% reported in the literature). Thus, there is an urgent need in the NICU for a smart FT that can provide safe navigation and evidence-based confirmation of gastric placement. EN management is also a central and ubiquitous priority for neonatologists. Many hospitals have adopted standardized feeding protocols, but personalizing nutrition management to each infant?s specific needs may improve development and overall outcomes. While appropriately advancing feeds is a priority, there is a delicate balance to achieve this while avoiding feeding intolerance (FI) and its complications. Accordingly, real-time, specific feedback regarding changes in infant digestive status may enable maximized nutrient delivery with early detection of FI. To meet the need for a next- generation FT, TheraNova has developed the Gravitas System, a smart FT that provides: (1) an evidence-based approach to guide and verify gastric placement and (2) a unique gastric status metric to guide nutrition management based on automated tracking of stomach contents. The Gravitas System consists of (1) an FT with embedded sensors and (2) a monitor which consists of an electronic controller and user-interface display. In our Phase I work, we confirmed the ability to accurately classify the anatomic location of the FT in a pre-clinical model and to measure the concentration of stomach contents in a bench-top model. The overall goal of this Phase II proposal is to validate the Gravitas System in NICU patients. First, we will conduct an observational study in the NICU to collect data for optimization of our FT placement algorithm (Aim 1). Second, using the optimized algorithm, we will conduct a pivotal study in the NICU to validate the accuracy of Gravitas FT placement vs. standard, blind placement (Aim 2). Third, in both of these studies, after FT insertion and throughout EN management, we will continuously record stomach contents to develop our gastric status algorithm for providing real-time data to clinicians regarding the patient?s digestive status (Aim 3). Successful completion of this proposed effort will support 510(k) clearance of the Gravitas System for guiding and confirming accurate FT placement in neonates. Data on gastric status tracking (Aim 3) will also enable a follow-on clinical study to validate this novel feature.
Annually, more than one million patients in the neonatal intensive care unit (NICU) require enteral nutrition (EN) in the U.S. Currently, feeding tubes are placed blind, resulting in high misplacement rates, and once placed in the stomach, they do not provide clinicians with data to guide personalized nutrition management based on each infant?s specific needs. We propose a smart feeding tube that provides: (1) an evidence-based approach to guide and verify gastric placement and (2) a unique gastric status metric to guide nutrition management based on automated tracking of stomach contents.
