Every 40 seconds, a baby dies from the complications of preterm birth, totaling over 2,000 babies globally per day. Preterm birth rates are rising, yet doctors have few reliable methods for determining which pregnancies are most at risk. When a baby is born prematurely, the risk of brain, developmental and respiratory problems increases – impacting the baby, their family and the healthcare system at large.
But what if doctors could prepare instead of react, anticipate instead of respond? What if they could identify risk before preterm birth begins?
Biomedical engineering students at Florida International University have helped develop a device designed to detect early signs of preterm labor risk in about five seconds. The system, called PPRIM (Portable Preterm Imaging), could flag risk up to three months earlier than current screening methods.
Professor of biomedical engineering Jessica Ramella-Roman runs FIU’s Medical Photonics Lab. She has been developing this technology for over a decade. Working in Ramella-Roman’s lab, doctoral students JunZhu (Jenny) Pei and Amanda Sanchez are leading the effort to commercialize PPRIM as PolarDoc. The team recently advanced to the final eight at this year’s Hult Prize competition.
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Every 40 seconds, a child passes away from the complications of preterm birth, we must do better.
More than one in 10 babies around the world is born preterm, and this rate is increasing.
In a biomedical engineering lab, doctoral student researchers Jenny Pei and Amanda Sanchez are working to mitigate these alarming statistics. They've helped develop a device to detect preterm labor. It's called PPRIM or Portable Preterm Imaging.
"The first time PPRIM revealed the earliest micro-structural changes that the old tools miss, I felt very excited because it meant that we could bring a whole new kind of information to patients. And this new information will help doctors prepare instead of react."
When a woman carries a baby to full term, she begins labor between 39 and 40 weeks into her pregnancy. A preterm birth occurs when her labor begins before 37 weeks.
Even when a mother escapes the worst case scenario, the problems don't stop there.
"Being born too early can affect both the baby and the mother. For the baby, they can have developmental effects on the brain, heart, lungs, and vision. And for the mother, there is an emotional toll that can lead them to have post-traumatic stress or just guilt for the rest of her life. If a woman has a preterm birth, it is three times more likely to happen again."
There can also be a financial toll beyond these medical and emotional impacts. Newborn intensive care for preterm births is extremely expensive. Hospital charges for a typical stay in a neonatal intensive care unit can cost up to $1 million.
Yet for all that heartache and expense, the current medical response to preterm births can only raise an alarm once labor has started. Consequently, doctors are forced to treat an emergency instead of preventing one.
"Today, a doctor has three main tools to check for preterm birth risk. The first one is digital, by feel. The second one is fetal fibronectin, which is a chemical marker. And the third one is ultrasound, which measures the length of the cervix, the organ that holds the baby in place. All three of these can tell you that preterm birth is happening. None of them tell us that it's coming."
The key to successfully preventing an early birth is to develop a way to reliably identify its signs well before it occurs.
"When a baby is born, it is delivered through the cervix. We can think of the cervix as a hammock that cradles the baby in place and slowly loosens to allow the baby to come out on time. Collagen is the protein that gives the cervix its strength and shape, similar to the rope fibers in the hammock. And in a healthy pregnancy, the rope fibers slowly disorganize on time to allow the baby to be delivered. In preterm labor, the rope fibers break down way too early."
PPRIM uses polarized light to capture rapid images of the cervix. It relays these images to a computer where specialized software analyzes changes in the cervix’s collagen structure. The team's software then analyzes those images by visualizing them as a color-coded map that can be read at a glance. Cooler colors indicate a lower risk of preterm labor, while warmer, fiery colors signal higher risk.
"Regular light can only look at the surface of the hammock. Polarized light however, can look at the individual rope fibers. Polarized light can do this because it travels with a very specific orientation. And when that light interacts with collagen fibers pulled tight in one direction and highly aligned, then we can get a very predictable pattern. However, when the collagen fibers lose their orientation and become more disorganized, that pattern is lost, and that is indicative of risk of preterm labor."
"PPRIM identifies a new warning sign that no one previously thought possible. And it does it faster than any other tool."
"Once we can see the risk early, doctors can actually go in with the proper early intervention, such as a simple stitch that would allow a pregnancy to go through properly."
The PPRIM is the brainchild of FIU professor Jessica Ramella-Roman, a world-renowned expert in optical imaging. She previously patented a method for using a polarized-sensitive optical technique to assess preterm birth risks. Since then, working in Ramella-Roman’s Medical Photonics Lab, Pei and Sanchez have overseen the evolution of PPRIM’s hardware and software designs. The duo is currently taking steps to bring PPRIM to market.
"For PPRIM to reach patients, there's a few steps that we need to go through. First, we're going to conduct a clinical trial to connect real data to patient outcomes. Second, we need to obtain FDA clearance. And finally, we want to scale the engineering and manufacturing to reach as many mothers as possible."
By becoming a standard of routine in OB-GYN visits, PPRIM will revolutionize obstetric care. A PPRIM exam takes only five seconds to complete. It is a more brief and minimally invasive procedure than currently available. And if the PPRIM exam reveals any disorganization in the fibers of the cervix, the issue can be addressed in time to ensure a safe, full-term birth.
"For anyone thinking about becoming a mother, tools like PPRIM that are on the horizon will give them hope for their future."