Device developed by MU automates oxygen levels for premature babies

When premature infants receive oxygen, the correct amount is important.

Currently, nurses or respiratory therapists manually turn a knob to increase or decrease the level of oxygen entering an infant’s lungs in response to alarms from a monitor.

Too much oxygen for a baby can lead to blindness. Too little oxygen can cause brain damage and other negative health effects.

A new device designed by a researcher at the University of Missouri’s College of Engineering would automate the procedure. Clinical trials are expected to begin at the MU Hospital for Women and Children and at a hospital in Pensacola, Florida, with 30 babies each.

Roger Fales, associate professor and associate dean at the College of Engineering, developed the device, in close consultation with John Pardalos, associate professor in the Department of Child Health at the MU School of Medicine.

Ramak Amjad is a co-inventor, Fales said. They started working on the device together when Amjad was at MU’s Women’s and Children’s Hospital. Both have a financial interest in Intelligent Respiratory Devices LLC.

Fales compared the device to a car’s cruise control that adjusts to keep speed constant even on uphill climbs.

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A device developed at the University of Missouri to automatically adjust oxygen levels for babies in the NICU is currently being tested in clinical trials.

Controlling a child’s oxygen is more complicated than that, Fales said.

“Every baby reacts differently,” said Fales.

This required the development of reliable models, he said.

Cooperation between engineers and medical researchers was essential, they said.

“I don’t have Dr. Pardalos’ medical history,” Fales said. “There has been a lot of back and forth between the engineering side and the medical side. We bring what we know about premature babies into the world of engineering.”

Current monitors have warnings that nurses decide they can’t believe, Pardalos said. Maybe that’s a number that doesn’t make sense when the baby has just kicked her in the leg. Or the child may be a healthy pink when a monitor indicates that oxygen levels are low.

The device had to be designed to recognize real situations and ignore fake ones, Pardalos said. This is something he advised Fales.

“The theory is that this machine learns to anticipate what the baby needs,” Pardalos said.

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The two have worked together since the late 2000s, doing modeling, comparing clinical data and performing bench tests, Fales said.

There is a national shortage of electronic chips, that the device uses. Fales said the shortage has been noticed, but so far he has been able to develop workarounds.

The clinical trial is expected to begin within the next few weeks, Fales said. It is funded with $ 414,149 from the federal government National Institutes of Health.

The trial will last six days, with babies on the device for six hours and with nurses using hand controls for six hours.

An independent statistician will analyze the data to determine if the device is performing as well as current practice, Fales said.

If this is positive, there could be further testing and approval by the federal government Food and drug administration.

“The goal is to turn this device into a product” with a company that produces it commercially, Fales said.

The main objective is humanitarian, he said.

“The main focus is to help babies in the NICU,” he said, referring to the neonatal intensive care unit.

The device can also potentially reduce the time nurses spend adjusting oxygen levels and responding to alarms, giving them time to deal with other aspects of the baby’s care, Fales said.

The clinical trials will allow engineering students to see how a new medical device can work in real conditions, Fales said.

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