A hospital’s neonatal intensive care unit (NICU) provides treatment and care for premature infants and other newborns with severe illnesses, injuries, or conditions. NICUs are specially equipped to address the needs of critically ill infants with medical equipment designed for very small bodies. But often these devices are simply downsized versions of tools created for older patients. There remains a need for new, specially designed tools and devices to better address infants’ unique needs and conditions.
Tonse Raju, M.D., chief of NICHD’s Pregnancy and Perinatology Branch (PPB), is working to meet that need. He helps develop funding opportunities to support small businesses in developing new technologies—including devices for monitoring babies’ health, measuring the activity of internal organs, and delivering medication—for the NICU.
We spoke with him recently to learn more about this important work. Here’s what he had to say.
Why is there a need for improved and new neonatal intensive care devices?
Neonatal intensive care is highly technology-dependent—we use many tools, devices, and materials to take care of sick newborns. However, most of the existing instruments are miniaturized versions of tools used for older patients. It’s rare to find instruments and devices that have been evaluated for efficacy and safety specifically in newborn infants and small children.
Many currently-used devices can cause pain, discomfort, or injury to newborns, who have delicate and unique physiologies. For example, endotracheal tubes, which we insert through the mouth and into the windpipe to help a patient breathe, must be taped to the side of the mouth to stay in place. Newborns have delicate, thin skin that tears easily when the tape is removed. The same is true for electrodes—sensors that adhere to the skin for monitoring heart or brain activity.
We also need better, noninvasive ways to measure substances in the blood and urine. A premature infant weighing just over 1 pound has only about 4 ounces of blood in his or her body—that’s as much as about a third of a can of soda. We sample infants’ blood at regular intervals by sticking their heels with a needle. An infant may receive as many as 2,000 heel sticks during a several-month stay in the hospital. We need better ways to conduct these tests.
Because of these gaps, in 2011, we developed a request for applications for small businesses to partner with academic researchers to develop new NICU technologies. The ultimate goal for these grants is to develop a technology, test its safety and effectiveness in clinical trials, and receive Food and Drug Administration approval.
What kinds of devices are NICHD-supported researchers currently developing?
Along with the National Heart, Lung, and Blood Institute, NICHD funded 22 applications as part of this recent initiative. Many of the projects aim to develop noninvasive technologies that monitor substances in the blood by measuring skin conductance, a gauge of how well the skin’s surface conducts electricity. One group is developing a skin conductance monitor that measures blood levels of glucose, which we must monitor daily while giving a patient intravenous fluids. Another team is working on a similar device—socks containing electrodes—that can measure levels of oxygen and carbon dioxide in the blood. We must monitor these substances if a patient is on a ventilator (a machine that helps with breathing).
Another project is using genomics (study of all the DNA in a single human cell) to develop methods of diagnosing infections that provide results within minutes, rather than the 48 to 72 hours it takes to have blood tested.
We use catheters—small tubes that go into veins—to give medicine and draw blood. However, blood can clot on and around catheters, and the clots can dislodge and travel to the lungs or brain. We have investigators working to develop special catheters that prevent clots from forming.
Some infants tend to get seizures, and we need to monitor their brain waves using an electroencephalogram (EEG). EEG monitoring is usually done by placing about 30 electrodes on the patient’s head. A newborn’s head is too small for 30 electrodes, and the electrodes must adhere to the head, which can tear infants’ delicate skin. So we have a group developing a newborn-sized head cap containing tiny electrodes that we hope will enable improved EEG monitoring in these patients.
These projects are all at different stages of development.
What is the greatest challenge in developing noninvasive neonatal devices?
One of the greatest challenges is building mutual understanding across specialties. Physicians don’t have a great understanding of the capabilities and limitations of engineers. Similarly, most engineers don’t have a good understanding of the specific complexities involved in neonatal intensive care or these patients’ medical and surgical needs. This grant program provides a way to bring both disciplines together, so they can understand each other and collaborate to come up with innovative ideas.
Another big challenge is that very few biotechnology companies are dedicated to developing instruments for small infants, because the market is very small. For that reason, even if promising devices move successfully through clinical trials, they often don’t make it to market.
Where do you see these efforts headed in the next 5 to 10 years?
The development of new bedside diagnostic devices is being revolutionized by the combination of nanotechnology—the engineering of devices on the scale of a single molecule—and microfluidic technologies, which involve systems that handle very small volumes of fluids. Another important area will be developing improved information technology so that neonatal devices can better inform us about a patient’s diagnosis, current status, and prognosis.
Regenerative medicine—using stem cells to transform and heal damaged tissues and organs—is another up-and-coming area. The field of genomics will allow us to create better diagnostic technologies. Another focus will be on identifying molecular biomarkers that can indicate the presence or status of a disease, how well organs are functioning, and whether an infant is ready to feed normally.
What else should people know about neonatal intensive care?
People should know about the technological needs of the neonatal intensive care field. Many people assume that hospitals are providing the best care possible, but don’t understand how limited some of our current practices are, or how important it is to stimulate research to improve them. Broader understanding of these needs will benefit the whole population in the long term.
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Information on neonatology research at NICHD
- Profile of Dr. Raju: A “fantastic specialty”
Originally Posted: July 14, 2015
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