SBIR-STTR Award

Over 1.8 million critically ill children and infants in the U.S. depend on enteral feeding each year. While nasogastric (NG) enteral feeding is life-saving, there are limitations to current technology with significant consequences. Specifically, when an NG tube is improperly inserted or dislodged after placement, the complications can be life-threatening. While radiography is the gold standard to verify tube placement, it is not suitable for children and infants due to cumulative radiation exposure, cost and time delay. Thus, 83% of neonatal nurses indirectly detect tube placement by aspirating gastric residuals (GR) of the stomach after tube insertion. Unfortunately, this method of measurement can be unreliable and potentially dangerous. Even with proper placement, pediatric and neonatal patients are subject to malnutrition due to under- and over-feeding. Energy deficiency is frequent in critically ill children and every calorie matters to promote both cognitive and physical development. However, a prevalent outcome of aggressive enteral feeding is the development of feeding intolerance (FI), which may result in multiple sequelae. Tracking gastric emptying (typically via GR volume (GRV)) provides key insight into both ample feed volume delivery as well as evidence of FI. However, the current method of GRV measurement is controversial as it is (1) invasive and (2) prone to error. While other metrics of gastric emptying, including residual food volume (RFV), may be superior, they are not universally used due to cost and equipment requirements. Critically ill neonatal and pediatric patients are particularly fragile, needing careful monitoring and fine tuning of their care. There are no devices available that continuously confirm safe positioning of the feeding tube and accurately monitor gastric function/health in real-time. To meet this need, TheraNova has developed the Gravitas System, a NG enteral feeding system that enables real-time detection of tube location as well as automatic tracking of gastric function via multiple parameters (GRV and RFV) in children. The Gravitas prototype has demonstrated early feasibility through studies in healthy porcine and human subjects. The goal of this Phase I proposal is to verify sensor and device performance on the benchtop and in vivo. In Specific Aim 1, we will establish long-term device performance on the benchtop. In Specific Aim 2, we will verify the sensor measurement thresholds used to determine device location in the digestive and respiratory tracts of weanling pigs. In Specific Aim 3, we will validate the accuracy of Gravitas’ GRV and RFV measurements both (1) on the benchtop with multiple anticipated confounding variables and (2) in weanling pigs. In future studies, we will continue to validate the device in a large-scale animal study and conduct a first study in children to validate the safety and effectiveness of Gravitas in assessing both (1) proper NG tube placement and (2) improved enteral nutrition. Development of this technology may play a pivotal role in reducing healthcare cost, and more importantly, improving development and survival in the vulnerable neonatal and pediatric patient population.

Public Health Relevance Statement:
Narrative Each year in the United States, over 1.8 million critically ill children and infants depend on enteral feeding each year while hospitalized. Although nasogastric enteral feeding is a life-saving therapy for these patients, there are limitations to current nasogastric feeding tubes with significant consequences from misplacement as well as malnutrition due to suboptimal delivery of nutrition. This Phase I SBIR project proposes the development of smart enteral feeding system that enables real-time detection of tube location as well as real-time tracking of gastric function to improve development and survival in the vulnerable neonatal and pediatric patient population.

Project Terms:
Acids; Address; Agreement; Algorithms; Analysis of Variance; Animals; Area; Aspirate substance; Barium Sulfate; base; Bluetooth; Bolus Infusion; Buffers; Calories; Caring; Catheters; Child; Cognitive; Color; Confounding Factors (Epidemiology); cost; cost effective; Critical Illness; Critically ill children; Dangerousness; Data Display; Detection; Development; Devices; Diagnostic radiologic examination; Duodenum; Effectiveness; Electric Conductivity; Enteral Feeding; Enteral Nutrition; Environment; Equipment; Esophagus; Exposure to; Family suidae; Fasting; feeding; Food; Future; Gastric Emptying; Gastric Stump; Gastrointestinal tract structure; Goals; Gold; Health; Health Care Costs; Human; human subject; improved; in vivo; Infant; innovation; insight; Life; Location; Lung; Malnutrition; Measurement; Measures; meter; Methods; Monitor; nasogastric feeding; Neonatal Nursing; neonatal patient; novel; nutrition; Nutritional; Outcome; patient population; Patients; pediatric patients; Performance; Phase; Phenolsulfonphthalein; Play; Polyurethanes; Positioning Attribute; Protocols documentation; prototype; Radiation exposure; Reference Standards; Residual state; Residual volume; Respiratory System; Risk; Roentgen Rays; Role; Safety; Savings; sensor; Small Business Innovation Research Grant; Specific qualifier value; Standardization; Stomach; System; Technology; technology development; Testing; Time; Tissues; Trachea; Tube; United States

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.

Public Health Relevance Statement:
Narrative 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.

Project Terms:
Adopted; Adverse event; Algorithms; Anatomy; Auscultation; base; blind; Blinded; Bottle feeding; Breast Feeding; Calories; Capnography; Carbon Dioxide; Clinical; Clinical Research; Cognitive; Data; Detection; Development; Devices; Duodenum; Early Diagnosis; electric impedance; Ensure; Enteral Feeding; Enteral Nutrition; Equilibrium; Esophagus; evidence base; Family suidae; Feedback; feeding; Feeds; Future; Gastric Feeding Tubes; Goals; Growth; Growth and Development function; Hospitals; Impairment; improved; Infant; Infant Development; innovation; Lead; Length; Length of Stay; Life; Link; Literature; Location; Lung; Measures; meetings; Methods; Modeling; Monitor; Morbidity - disease rate; mortality; nasogastric feeding; Navigation System; Neonatal Intensive Care Units; neonate; next generation; novel; Nurses; Nutrient; nutrition; Nutrition management; Nutritional; Observational Study; Outcome; Patients; pediatric patients; Phase; Polyurethanes; Population; Pre-Clinical Model; Procedures; Protocols documentation; Randomized; Reporting; Residual state; respiratory; Savings; sensor; Source; Specificity; standard of care; Standardization; Stomach; Stomach Content; System; Techniques; Temperature; Time; Training; Weight; Weight Gain; Work