Seattle Children’s Research Institute Secures $3 million for Seattle-PAP Infant Breathing Support Invention
Grant from the Bill & Melinda Gates Foundation will fund clinical trials as the device’s next step in its path to broad use
Today, Seattle Children’s Research Institute announced the receipt of a three year, $3 million dollar grant from the Bill & Melinda Gates Foundation to conduct two clinical trials of Seattle-PAP, an affordable device intended to provide breathing support to premature infants. 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 healthcare resources may be limited. To operate the device, only relatively simple supplies are needed, including water, a continuous air supply, a breathing circuit tube, and a tube for the nose.
“Worldwide, almost 1 million infants die each year from respiratory distress. Most of these deaths occur in resource-limited countries due to a lack of access to respiratory support devices commonly used in the developed world,” said Thomas Hansen, MD, CEO at Seattle Children’s. “Seattle-PAP may be a solution to this problem by making effective respiratory support accessible to newborns anywhere in the world.”
The team’s work to develop Seattle-PAP and prepare it for clinical trials was funded by a previous grant from the Gates Foundation. In October 2013, Seattle-PAP received the U.S. Food and Drug Administration’s (FDA) 510 (k) clearance, which allows use of the device and commercial distribution within the U.S.
Path to broad clinical use: trials, regulatory clearance and building a reliable method for data collection
The first of the two Texas Children’s Hospital clinical trials will test the hypothesis that Seattle-PAP makes it easier for premature babies to breathe than do other noninvasive respiratory support devices used in healthcare facilities worldwide. The second trial will test the effectiveness of Seattle-PAP in preventing respiratory failure in infants with respiratory distress.
“As the largest NICU in the nation, caring for nearly 3,000 babies each year, we are optimistic about the potential benefits Seattle-PAP will have for our premature and critically-ill infants,” said Stephen Welty, MD, chief of neonatology in the Division of Neonatology, Department of Pediatrics at Baylor College of Medicine and section chief for the Newborn Center at Texas Children’s Hospital. “Further, we are encouraged that our trial could lead to the widespread use of this technology and provide access to life-saving care for babies worldwide.”
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. Therefore, as part of the new grant’s work, the Seattle-PAP team is also working with Intellectual Ventures Laboratory to design and construct what the team has named 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 Seattle-PAP is suitable for use in the European Union.
Seattle-PAP makes breathing easier for babies with respiratory distress
Seattle-PAP works like conventional nasal B-CPAP (Bubble Continuous Positive Airway Pressure) devices, which provide continuous positive pressure on the infant’s lungs via tubes inserted in the nostrils. This continuous pressure prevents the infant’s lungs from collapsing completely and helps them breathe. Seattle-PAP may be different from other B-CPAP devices because its novel design creates both continuous pressure and pressure oscillations. These oscillations are thought to lessen the work required from respiratory muscles, thus making it easier to breathe.
Respiratory muscle exhaustion is a major cause of failure in conventional nasal B-CPAP therapy. These failures, which occur in approximately half of babies using this therapy, often necessitate the need for endotracheal intubation and mechanical ventilation that carry the risk of tissue damage and inflammation.
If, as preclinical trials data suggest, Seattle-PAP reduces the work an infant has to do to breathe, the device could eliminate the need for endotracheal intubation and mechanical ventilation in many infants. In the resource-limited healthcare settings where endotracheal intubation and mechanical ventilation are often not available, Seattle-PAP may become the only practical way to provide respiratory support to the babies who need it.
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