A universal ambient air-oxygen blender to treat respiratory distress in newborns

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Approximately 3 million neonatal deaths occur annually due to prematurity, intra-partum related conditions and infections, with respiratory distress being a serious condition being experienced by the newborn in each case. A common treatment to treat respiratory distress is by providing oxygen-enriched air to the neonate using a continuous positive airway pressure (CPAP) device. A common configuration of these devices involves connecting the device to a medical grade oxygen and air tanks upstream from the newborn to titrate the oxygen content using a blender, which also controls the flow rate of the oxygen-enriched air. A pressure generating water bottle with a straw is connected downstream so that the newborn exhales against pressure defined by the water depth to which the straw is inserted, thus inflating lungs and providing unimpeded respiration. There are two limitations of current commercial CPAP devices. First, they are designed to require wall electricity to operate the sensors and humidifier, which prevents treatment during pre-hospital and intra- hospital transport. Second, lack of availability of medical grade air especially in resource poor regions worldwide have led to improvised devices delivering 100% oxygen causing severe oxygen toxicity-related complications such as retinopathy of prematurity and bronchopulmonary dysplasia. In this proposal, we hypothesize that a universal ambient air-oxygen blender with remote monitoring capability and delivering oxygen-enriched air over a wide range of FIO2 will enable a bubble-CPAP device to be portable, while also functioning effectively with commercially-available CPAP devices. As our pilot data show, the percentage of oxygen can be varied over a wide range of FIO2 in a controlled manner at clinically relevant flow rates. We used this data to invent a universal ambient air-oxygen blender equipped with a downstream FIO2 sensor and flow rate gauge, allowing the healthcare provider to control FIO2 and flow rates, regardless of the CPAP to which it is connected. The Specific Aims are: first, to test the hypothesis that a universal ambient air-oxygen blender with remote monitoring capability will enable a bubble-CPAP device to be portable by designing, fabricating and testing a prototype bubble-CPAP device; second, to test the hypothesis that the ambient air- oxygen blender will functioning effectively when the module is integrated with commercially-available CPAP systems that currently rely on both medical grade oxygen and air tanks. Successful completion of this project will provide a portable CPAP device for transport as well as hospital bed use, allow integration of an ambient air-oxygen blender with other CPAP devices making it unnecessary to improvise devices to deliver 100% oxygen that can cause organ damage and enable remote monitoring to ensure smooth functioning of the device.