Despite having the medical training to treat the breathing problems of prematurely born babies, doctors in places with fewer resources are continually frustrated by the lack of technology to do so properly.
“They are trained medical experts and they know what to do, but without the appropriate devices and tools to do the job, they’re just seeing these lives fade away,” said Anjelica Gonzalez, the Donna L. Dubinsky Associate Professor of Biomedical Engineering. “I can’t imagine doing that every day of my life.”
More than 1.5 million newborns die each year from respiratory complications. Overwhelmingly, these deaths occur in low- and middle-income countries due to a simple lack of resources. To counter that, Gonzalez is leading a team of researchers in the development of PremieBreathe, a low-cost infant respirator that delivers warmed, humidified, and oxygenated air to reduce airway irritation and keep infants breathing normally. The project has received $250,000 in funding from Saving Lives at Birth, a partnership that includes the U.S. Agency for International Development (USAID) and the Bill & Melinda Gates Foundation.
The cross-campus collaboration began in 2012 with a request from the Yale Institute of Global Health and includes faculty from the School of Engineering and Applied Science (Gonzalez, Mark Saltzman, and Joseph Zinter); the School of Medicine (Dr. Lei Chen and Dr. Linda D. Arnold), and the Office of Cooperative Research.
Arnold and Lei, who had earlier researched the issue in Rwanda, advised on clinical specifications; the Gonzalez lab undertook the task of engineering, design, and testing. Students who had previously been in Gonzalez’s course “Biotechnology and the Developing World” reached out to her with interest in working on real-world problems. These students were afforded the opportunity to work with her and senior research scientist Larry Wilen of the Center for Engineering Innovation and Design as their senior projects to help build the initial version of the device.
When Gonzalez first visited hospitals and clinics in Ethiopia and Malawi, she immediately saw the need for safe and well-regulated devices that could deliver air to babies. Some places are so desperate for devices that they create makeshift respirators out of soda and water bottles. Because water and heat are the perfect recipe for mold, fungus and bacteria, infants sometimes end up with hospital-acquired infections.
“The thing that sticks with me is that, having kids myself, it’s not fair that other children don’t have the same opportunities for healthcare, which I consider a human right,” Gonzalez said. “We need to do the most we can to make sure that babies within these communities have the chance to survive.”
Michael Skonieczny, deputy director of the Yale Institute for Global Health (YIGH), said the project shows what can be accomplished when different fields of expertise come together to take on a major issue.
“PremieBreathe’s history of initial work in Rwanda and partnerships with other departments, faculty, and students from across campus, demonstrates how big results can be achieved from a collaborative effort,” Skonieczny said. “PremieBreathe is a great example of what we can do through YIGH to encourage strong collaboration between Yale faculty and partners around the world.”
Work on PremieBreathe is based on the idea of what’s known as “appropriate design,” a collaborative process between engineers and the people who will be using the device.
“When we refined the design of PremieBreathe, we worked with the hospitals in Ethiopia, where we still have collaborations,” Gonzalez said. “We spoke with their biomedical engineers, their physicians and nursing staff to figure out what makes sense in the context of their available infrastructure and support.”
Together, they figured out a way to build a safe and inexpensive unit that would be rugged enough to withstand the less-than-ideal conditions of some district clinics and community health centers in developing countries.
The design has undergone about a half-dozen iterations; it’s been tweaked to make it more durable, reduce its size, and make sure the specifications are exactly what they need to be. In addition to performing at the same level as typical respiratory systems, Gonzalez said, the device needs to be easy to operate and easy to maintain. Too often, she said, medical equipment will go to places that don’t have the resources to keep them operating if they break down.
The researchers are currently at the point where they are shoring up prototypes for bench-testing. By October they hope to have data from the first round of tests in Ethiopia. When they’re satisfied that the device’s design is ready, Gonzalez said, they plan to create many more units to accommodate the different levels of care. In places like Malawi and Ethiopia, she said, infants born pre-term in a small community hospital need to be moved to larger facilities, but still need immediate respiratory care before and during transportation.
“The infrastructure in those settings looks a lot different from those of larger hospitals,” she said. “So ultimately, we want to make sure that all of these care facilities are supported by these devices.”