This project aims to develop continuous pulse oximetry monitoring technology to facilitate the care of infants after they have transitioned from the neonatal intensive care unit (NICU) to home. This technology targets the monitoring of neonates with chronic lung disease of infancy (CLDI), a group of respiratory diseases that usually evolves from an acute respiratory disorder experienced by a newborn infant. Advances in perinatal care, changes in health care economics, and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for infants with CLDI. The home environment has increasingly been recognized as the optimal setting for medically stable, technology assisted infants to receive the complex and demanding care they require. Infants in the NICU are commonly connected to multiple pieces of equipment and monitors. While this lifesaving technology is a necessary part of providing care to these infants, the many wires can also add to the complexity of caring for these infants, particularly in a home environment with untrained personnel. Very recent advances in electronic components allow miniature wireless medical instrumentation to be developed that is of a size and weight appropriate for a long-term wearable neonate application. This project includes a unique team of medical device experts with a history of FDA approved products, research neonatologists, pulse oximetry design experts, and a human factors expert. Testing will include FDA recommended 510(K) safety and performance evaluations, a desaturation study, and a gold standard comparison evaluation in neonates.
Chronic lung disease of infancy (CLDI) is a group of pulmonary disorders that start in the neonatal period. Often the inciting factor is bronchopulmonary dysplasia (BPD), a chronic condition that usually evolves after premature birth and respiratory distress syndrome due to surfactant deficiency. BPD is the most common pulmonary morbidity in preterm infants and affects approximately 5,000 to 10,000 infants in the United States each year.
