Every year, 15 million babies are born too early, with 1 million never making it to their next birthday. And in low-resource settings, the outlook is even more dire. Half of babies born at 32 weeks or earlier will die; whereas in high-resource settings, almost all of these babies survive.

To help bridge this gap, an interdisciplinary team of Northwestern University researchers has developed a new wireless, battery-charged, affordable monitoring system for newborn babies that can easily be implemented to provide clinical-grade care in nearly any setting.

The new devices also exceed the capabilities of existing, wired monitoring technologies to provide information beyond traditional vital signs, including crying, movement, body orientation, and heart sounds. These soft, flexible sensors also are far gentler on newborns’ fragile skin, and their wireless capabilities allow for more skin-to-skin contact with parents.

Not only can this technology lower risks by monitoring babies, it also can monitor pregnant women during labor to ensure a healthy and safe delivery and reduce risks of maternal mortality. By closely monitoring the most vulnerable patients, physicians can be alerted to intervene before the infant or mother become seriously ill.

Details about the technology were published in the journal Nature Medicine, with extensive tests on newborns at Ann & Robert H. Lurie Children’s Hospital of Chicago and Prentice Women’s Hospital in Chicago. The sensors described in the paper also are now being tested on newborns at Aga Khan University Hospital Nairobi, Kenya and on pregnant mothers in the University Teaching Hospital in Lusaka, Zambia.

From the Hospital to the Home to the Field

Led by Northwestern’s John A. Rogers, a pioneer in the emerging field of bio-integrated electronics, the research team developed the sensors last year and tested them on babies in the United States. Now, with support from the Bill & Melinda Gates Foundation and Save the Children, the team is deploying the devices internationally, starting with hospitals in Ghana, India, Kenya, and Zambia.

“We designed our technology to offer affordable, clinical-grade monitoring capabilities for use anywhere in the world — from the hospital to the home to the field,” Rogers says. “Using advanced concepts in soft electronics, we achieved devices that are safe, easy to use, and patient-centric. We included in our research a focus on features to allow application in low-resource settings in the developing world, where this type of technology has the greatest potential to improve and possibly save lives.”

Reliable in Areas Without Stable Power

To move these platforms from Chicago into the developing world, Rogers’ team added a small, thin, rechargeable battery to give the device stable, reliable power for operation in rural settings and to improve the wireless operating range. The team also added extra sensing capabilities to monitor crying, movement and heart sounds.

“We couldn’t just drop our existing technology into other countries and different settings without taking their specific needs into account,” Rogers says. “We wanted to understand the broader landscape and to develop a technology that is easy-to-use, helpful, and practical. We knew that we needed to build the foundations for highly robust, reusable devices, applicable in regions with limited facilities and resources.”

“Some areas experience rolling blackouts every day and uneven internet coverage,” says Dr. Shuai (Steve) Xu, a Northwestern Medicine dermatologist and co-first author of the study who leads deployment of the system on the ground. “People in these areas need a practical device that works and is cheaper to manufacture.”

Sensors Send Data to Mobile Devices

The sensors use radio frequencies to wirelessly transmit data from the baby to nurses’ station displays. They also can send data directly to a smartphone or tablet. “The beauty of the technology is that it can operate with a wide range of mobile devices without sacrificing accuracy, relative to the most sophisticated systems used in hospitals today,” Xu says.

The device uses radiofrequencies to wirelessly transmit data from the baby to nurses’ station displays. (Credit: Northwestern)

Xu, assistant professor of dermatology and pediatrics at Feinberg and assistant professor of biomedical engineering at McCormick, is also the medical director of the Querrey Simpson Institute for Bio-electronics. He has spent the past six months leading a team of engineers in setting up the technology in hospitals in Kenya and Zambia, working with nurses and physicians. The program will involve testing the sensors on 15,000 pregnant women and 500 newborn babies by mid-2021.

So far, 42 babies in Kenya have worn the wireless sensors alongside gold standard, traditional monitoring systems so researchers could do a side-by-side, quantitative comparison. After validating the device at Aga Khan University Hospital, the team plans to move the technology to low-resource hospitals in rural Africa, where the need is greatest.

Collaborating with Nurses

Rogers and Xu say the early feedback from hospital nurses has been invaluable. The sensors work in pairs — one on the chest and one wrapped around a foot. In an earlier version of the technology, nurses worried that the chest sensor might be too large for small, fragile newborns. Rogers and his team immediately responded to this feedback to make a smaller, thinner chest device. Nurses also have struggled with perfecting the foot sensor’s alignment. If the sensor is not correctly wrapped around the foot, then the data are not as accurate.

“It takes some practice to quickly align the foot sensor,” Rogers says. “So we designed a system that lights up as red, yellow, or green — incorrect, close, or in the right place — depending on the accuracy of the alignment, to provide feedback to the caregiver.”

The soft, flexible sensors are gentle on newborns’ fragile skin. (Credit: Northwestern)

Scalability, AI, and Hospital Placement

With an exclusive license to the technology from Northwestern, Rogers and Xu launched Sibel Health to scale the technology and to earn FDA approval later this year, with a focus on maternal, fetal, neonatal, and pediatric health. More recently, Sibel announced a strategic partnership with Dräger.

Next, Rogers and Xu plan to incorporate artificial intelligence into the sensors to extract insights from the data and provide health care professionals with recommendations for care.

“These systems are generating half a gigabyte of data for one patient a day. That’s a lot of physiological information,” Xu says. “We’d like to use clinically validated algorithms that could, for example, tell us if a baby is likely to develop sepsis within the next 24 hours based on their vital signals. Then we could have ventilators and antibiotics ready to escalate care almost proactively. For pregnant women, we’re working with Dr. Jeffrey Stringer — the director of the division of Global Women’s Health at University of North Carolina at Chapel Hill — with funding from the Bill & Melinda Gates Foundation to more quickly identify danger signals in low-resource settings.”

Rogers estimates these new wireless sensors could appear in U.S. hospitals within the next year. His team also expects to send sensors to more hospitals in countries around the world as part of an ongoing international effort to improve affordable healthcare monitoring.

The paper’s first authors, who are all from Northwestern, are Ha Uk Chung, Alina Rwei, Aurélie Hourlier-Fargette, and Dr. Xu.

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Medical Design Briefs Magazine

This article first appeared in the June, 2020 issue of Medical Design Briefs Magazine.

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