As a pediatric heart surgeon and research scientist, Danielle Gottlieb Sen has long felt the need for a simple, noninvasive monitoring device that babies with congenital heart disease could wear — the way their parents might wear a smartwatch — to track how well their heart is functioning when they go home between surgeries.
“It’s called the interstage period, and there’s a pretty high risk of mortality,” says Gottlieb Sen. “And we know the risk is higher in groups affected by health disparities — things like ethnicity, income and geographical distance from a heart center, which we call social determinants of health. As a surgeon, I felt I would see patients come back in better shape if I had a way to monitor them remotely.”
But it wasn’t until she joined the Blalock-Taussig-Thomas Pediatric and Congenital Heart Center in April 2020 that Gottlieb Sen was able to start making serious progress toward realizing her vision. “Because of the strength of the Hopkins engineering program, I found real partners to work on the technology I had in mind,” she says. “We are very close to having a device we hope to be able to offer parents so we can collect the kind of data at home that we are now able to collect only in the hospital.”
Gottlieb Sen describes the process of designing the device as “iterative,” meaning you design and test, redesign and test, and do this repeatedly until you have exactly the product you want. In collaboration with Johns Hopkins Children’s Center neonatologist Christopher Golden, medical director of the newborn nursery, Gottlieb Sen and her team are now testing a promising model of the device in babies. Together, they are running a pilot project to see how well the device is able to collect data, first from healthy infants, and ultimately from babies with heart disease.
“When Danielle approached me last year about getting this pilot going, gathering cardiac and vital sign data from healthy babies and using that data to develop a way of monitoring babies with congenital heart disease, there wasn’t a moment’s hesitation,” Golden says. “This would be a very important advance for our patients at the Children’s Center, especially as we develop our pediatric heart center. It fits perfectly into our essential mission — to provide the best possible outcome for newborns, including babies with heart disease.”
Golden enlisted colleague Julie Nogee, a neonatologist with a special interest in congenital heart disease, and they started recruiting. Parents were eager to help, Golden says.
“As soon as we explained the purpose of the study and what was involved, parents said they’d be delighted to allow their babies to participate in a study that might help other families,” says Golden. “They have been incredibly generous, and we couldn’t do this without them.”
Gottlieb Sen describes the monitoring device as a small article the baby wears comfortably on its body. Babies have very specific design requirements, especially for a device that would have to be worn long term. It has to account for the fact that they are constantly moving. It can’t impede movement or circulation. And it can’t be attached directly to their very sensitive skin.
“With the noninvasive device we’ve designed, we can monitor multiple vital signs simultaneously, collect that data in one place in real time, and catch changes that might signal a need for immediate intervention,” she says. “We are collecting many of the same vital signs that we routinely collect in an intensive care unit on a device that can be worn at home. And in the future, there is the potential of adding more modules of data that we might be able to collect.”
There is a possibility that physicians may someday monitor all newborns at home, gathering data that might lead to insights into and treatments for other conditions, including sudden infant death syndrome. “Monitoring patients remotely sort of gets at where we are going in medical care — from invasive to noninvasive, from inpatient to outpatient, from crisis care to prevention. It’s not only less expensive, it may produce better outcomes for our patients,” Gottlieb Sen says.
She and her team have already begun work on even more ambitious infant monitoring devices, including an iteration that would use artificial intelligence to determine a baby’s health status without the need for a clinician’s interpretation of the raw data. And she has many, many collaborators, including fellow clinicians in the Johns Hopkins Children’s Center newborn intensive care unit, cardiac catheterization lab and pediatric cardiac intensive care unit, as well as outside of Johns Hopkins.
Months before she came to Johns Hopkins, Gottlieb Sen reached out to Youseph Yazdi, executive director of the university’s Center for Bioengineering Innovation and Design, and she has been working with him ever since. Each year for the past three years, she has collaborated with teams of Johns Hopkins engineering students on various monitoring technologies.
She has also collaborated with faculty and students at the Johns Hopkins Bloomberg School of Public Health to survey parents and physicians on what they are looking for in cardiac monitoring devices. And the FastForward program at Johns Hopkins Technology Ventures has brought its expertise in the business of developing new technologies to bear on her projects.
“These kinds of concepts can’t be executed without a multidisciplinary team, and that’s the incredible strength of Hopkins,” she says, citing its long history of innovation, beginning with the storied interdisciplinary team — led by Alfred Blalock, with Helen Taussig and Vivien Thomas — that in 1944 developed the now famous procedure to palliate the congenital heart defect known as tetralogy of Fallot (blue baby syndrome).
“We have a long tradition of working together,” says Gottlieb Sen, “across many, many departments and disciplines, to improve outcomes for our patients.”