SBIR/STTR Award attributes
Abstract Overmillion critically ill children and infants in the U Sdepend on enteral feeding each yearWhile nasogastricNGenteral feeding is life savingthere are limitations to current technology with significant consequencesSpecificallywhen an NG tube is improperly inserted or dislodged after placementthe complications can be life threateningWhile radiography is the gold standard to verify tube placementit is not suitable for children and infants due to cumulative radiation exposurecost and time delayThusof neonatal nurses indirectly detect tube placement by aspirating gastric residualsGRof the stomach after tube insertionUnfortunatelythis method of measurement can be unreliable and potentially dangerousEven with proper placementpediatric and neonatal patients are subject to malnutrition due to underand over feedingEnergy deficiency is frequent in critically ill children and every calorie matters to promote both cognitive and physical developmentHowevera prevalent outcome of aggressive enteral feeding is the development of feeding intoleranceFIwhich may result in multiple sequelaeTracking gastric emptyingtypically via GR volumeGRVprovides key insight into both ample feed volume delivery as well as evidence of FIHoweverthe current method of GRV measurement is controversial as it isinvasive andprone to errorWhile other metrics of gastric emptyingincluding residual food volumeRFVmay be superiorthey are not universally used due to cost and equipment requirementsCritically ill neonatal and pediatric patients are particularly fragileneeding careful monitoring and fine tuning of their careThere are no devices available that continuously confirm safe positioning of the feeding tube and accurately monitor gastric function health in real timeTo meet this needTheraNova has developed the Gravitas Systema NG enteral feeding system that enables real time detection of tube location as well as automatic tracking of gastric function via multiple parametersGRV and RFVin childrenThe Gravitas prototype has demonstrated early feasibility through studies in healthy porcine and human subjectsThe goal of this Phase I proposal is to verify sensor and device performance on the benchtop and in vivoIn Specific Aimwe will establish long term device performance on the benchtopIn Specific Aimwe will verify the sensor measurement thresholds used to determine device location in the digestive and respiratory tracts of weanling pigsIn Specific Aimwe will validate the accuracy of GravitasGRV and RFV measurements bothon the benchtop with multiple anticipated confounding variables andin weanling pigsIn future studieswe 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 bothproper NG tube placement andimproved enteral nutritionDevelopment of this technology may play a pivotal role in reducing healthcare costand more importantlyimproving development and survival in the vulnerable neonatal and pediatric patient population Narrative Each year in the United Statesovermillion critically ill children and infants depend on enteral feeding each year while hospitalizedAlthough nasogastric enteral feeding is a life saving therapy for these patientsthere are limitations to current nasogastric feeding tubes with significant consequences from misplacement as well as malnutrition due to suboptimal delivery of nutritionThis 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
