A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation

PROJECT SUMMARY/ABSTRACT Ten percent of the approximately four million infants born in the United States each year are born premature (<37 weeks gestational age). Preterm birth prior to the maturation of critical neonatal body systems results in prolonged hospitalizations that impose an annual societal cost burden of $26 billion. Achievement of the ability to fully orally feed is often the last developmental milestone these infants achieve, with the time it takes for patients to meet this milestone accounting for as much as 90% of the variance of their total length of hospital stay. In addition to prolonging neonatal hospital stays these swallowing deficits (dysphagia) pose detrimental health effects including pulmonary aspiration, cardiopulmonary instability, and malnutrition. Early diagnostics and treatment are critical to maximizing neonatal health outcomes and reducing hospital expenditures. While the gold standard videofluoroscopic swallow study is an effective diagnostic method, its emission of harmful radiation limits its regular clinical utilization. The available alternative assessment, clinical observation, is subjective with inherent limitations in its validity of detecting underlying deficits. nuBorn Medical has developed a SMART bottle that allows for the non-invasive objective assessment of an infant's oropharyngeal sucking and swallowing abilities. With this tool clinicians can identify swallowing deficits and determine the appropriate treatment regimens to enable earlier and more accurate methods of dysphagia management than in the current standard of care. In this Phase II STTR investigation, nuBorn Medical's SMART bottle will undergo its final stages of product refinement to maximize user experience, and and gather critical information necessary to substantiate claims in its upcoming FDA application.