Regulaire: A Closed-Loop Oxygen Controller for Premature Infants

To help reduce the incidence of retinopathy of prematurity, bronchopulmonary dysplasia, and other complications related to hyperoxia/hypoxia in premature infants, we have designed a system which will automatically monitor the blood oxygen saturation (SpO2) levels of the infants and will adjust the fraction of inspired oxygen (FiO2) when necessary in order to keep the saturation levels within a specified range. The current standard of care involves nurses monitoring several infants and manually adjusting FiO2 levels as needed. Our system will improve upon this standard by monitoring a single infant in real time, allowing it to react with more speed and precision. The final design will minimize the amount of time spent by the infant outside of the SpO2 target range when on oxygen therapy, thereby reducing the risk of ROP and the number of alarms in the clinical environment. It will also free up more time for the nurses to attend to the infants in other ways. The system will first be tested in a neonatal simulation center under various simulated conditions. It must be able to react to a wide range of trends in the given SpO2 values, including both gradual and rapid fluctuations, and it must react to these trends in ways similar to how the nurses react. If the system can be shown to be effective, it will be tested in a neonatal intensive care unit against the current standard of care.