The trials will begin later this spring in the neonatal intensive care unit (NICU) at Texas Children’s Hospital, the largest NICU in the U.S., and will confirm whether Seattle-PAP fosters similar or better outcomes than other infant breathing devices, as preclinical research suggests. If results are favorable, Seattle-PAP, which was developed in-house at Seattle Children’s Research Institute, is expected to be commercially available to healthcare providers around the world by 2017.
Developed by a team co-led by Seattle Children’s CEO Tom Hansen, MD and Charles (Skip) Smith, PhD, Seattle-PAP is significantly cheaper to produce, operate, maintain, and repair than ventilators and other respiratory support devices typically used in U.S. healthcare facilities. These features make Seattle-PAP ideal for use in areas where access to health care resources may be limited.
The reliability of data collected in these studies will be key to interpretation of results and will be critical to provide the medical community with the necessary data to support the device’s uptake and use around the world. As part of the new grant’s work, the Seattle-PAP team is working with Intellectual Ventures Laboratory to design and construct the DAta ReCording Instrument (DARCI), to monitor and record device performance during the trials.
To aid in Seattle-PAP’s path to broad clinical use, Seattle Children’s Research Institute will also work to earn the CE Mark, which will indicate that the device is suitable for use in the European Union.