Pedi-Sync: A Clinical Decision Support Tool to Improve Oral Feeding Outcomes in Preterm Infants

At present, in the US, one out of every ten infants is born prematurely and many of these babies are admitted to a Neonatal Intensive Care Unit (NICU) in order to help them survive and thrive. Successful oral feeding is a requirement for discharging infants home from the NICU. However, an estimated 80% of infants born prematurely struggle with their oral feeding skills and inadequate oral feeding is the most common barrier to hospital discharge. The current practice for infants who cannot successfully feed is to remain longer in the NICU at an average cost of $7000 per day and a national cost of more than $26 billion a year. To address this problem, NeoCare Innovations, Inc. invented Pedi-Sync, a novel clinical decision support tool for improving care in the NICU. Pedi-Sync addresses the economic burdens of health care for preterm infants in NICUs across the US by lowering expenses through cost effective technology. Pedi-Sync optimizes feeding of the preterm infant as it quantifies an infant’s oral feeding performance, or more specifically a baby’s ability to coordinate swallowing and breathing while feeding. Pedi-Sync consists of (1) a portable, stand-alone unit able to measure physiological data (heart rate, respiratory rate, oxygen saturation, and respiratory waveform variability of transthoracic impedance), (2) a software application housed within the unit that runs the device’s clinical algorithm, and (3) a mobile app used by clinicians to input oral feeding assessment data. The algorithm combines the recorded physiological data with the infant’s demographic information and feeding performance data to generate an oral feeding adaptability score. The oral feeding adaptability score is a quantitative measure of how well an infant can coordinate their breathing and swallowing. Specific Aims under this Phase 1 effort will include prototype hardware and software development, data aggregation, proof of product, and feasibility testing. A cloud-based hardware/ software co-designed platform will be developed and tested. A data collection program that extracts, compiles, and combines relevant electronic health record data with the infant’s respiratory variability values and feeding outcome measures will be created. Pedi-Sync will demonstrate feasibility for clinical use on 30 preterm infants. Completion of the Phase I project will then support a Phase II program that is focused on prototype testing addressing standard FDA required assessments and human subjects testing. Pedi-Sync will significantly improve health care by introducing novel and medically precise technology for NICU care. This innovative device will inform clinical decisions with the ultimate goal of improving patient care outcomes at a lower cost while enhancing the infant, family and staff experience. Providing objective data for clinicians to accurately assess and progress oral feeding skills will result in earlier discharge from the NICU substantially reducing healthcare costs.