NEC Check
- Alina Andrews
- David Maher
- Elizabeth Russo
- Madeline Wartan
- David Zarrin
- David Hackam, MD
- May Chen, MD
- Mark Kovler, MD
- Emily Dunn, MD
- Youseph Yazdi, PhD
- Soumyadipta Acharya, PhD
- Aditya Polsani, MS
- Joshua de Souza, MSE
- Medtronic, Minimally Invasive Therapies Group (Boulder, CO)
Abstract:
Necrotizing Enterocolitis (NEC) is an inflammatory disease that causes bowel necrosis in premature infants. It is the number one cause of death in infants weighing less than 1500 grams and the number one surgical emergency among all patients in the Neonatal Intensive Care Unit (NICU). 380,000 infants are born prematurely annually, with over 90,000 at elevated risk for developing NEC. This disease can onset acutely and severely, causing seemingly healthy infants to undergo surgery within 24 to 48 hours. Current diagnostic methods, which include physical examinations and abdominal X-rays, are not sensitive and specific enough to facilitate early detection of NEC. Physical examinations consist of manual abdominal girth measurements and auscultation. These assessments are both subjective and infrequent, as they occur every three to four hours. X-ray, the diagnostic gold standard, is only effective at diagnosing late-stage NEC. These limitations result in a large percentage of the 5,400 infants diagnosed with definite NEC each year to require surgical intervention since medical treatment was initiated too late. Surgical intervention carries a 30% mortality rate that results in over 800 infants dying each year. Our solution for earlier NEC detection is a novel four-quadrant abdominal patch sending output data to an algorithm that is capable of objectively and continuously monitoring the earliest physiological and clinical indicators of the disease: reduced bowel sounds and altered gut perfusion. This proprietary algorithm will continuously isolate bowel sounds from ambient and environmental noise in neonatal critical care settings to estimate gastrointestinal motility levels. A separate algorithm will analyze temporal perfusion changes by trending regional oxygen saturation (rSO2) values in real-time. In combination, these objective metrics of gut perfusion and gastrointestinal motility will guide medical management of neonates. Integrating NEC Check into the current standard of care for this patient population can quickly alert providers of changes in abdominal health.