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.
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.
