Philips and Duke University School of Nursing will be piloting a new remote monitoring technology for premature babies, the companies announced today. The study will use Philips' recently FDA-cleared InnerSense device, a feeding tube which doubles as a core temperature sensor, to monitor the infants for signs of hypothermia. The tube connects via a cord to a Philips bedside monitor.
"Monitoring core temperature is critical for caregivers in helping to reduce mortality and morbidity among infants," Michael Mancuso, CEO of Patient Care and Monitoring Solutions, a division of Philips Healthcare, said in a statement. "The Philips InnerSense technology provides caregivers with critical and relevant temperature measurement data when they need it most, while minimizing frequent disruptions and keeping infants comfortable."
According to Philips, infants with a birthweight under 1,500 grams (3 pounds, 3 ounces) often lack the ability to regulate their own body heat during their first 24 hours of life and can succumb to hypothermia as a result. Because they are so small and delicate, it's difficult to find the right means to monitor their core body temperature.
"Studies show that esophageal temperature is a more accurate, more precise, more responsive, and more reliable surrogate for core (peripheral artery) temperature than are rectal, axillary, or skin temperatures," Philips writes on the InnerSense website. "In these fragile patients, temperature changes can be sudden and dramatic, and skin temperature sensors or axillary spot checks do not promptly reflect what’s going on internally."
In the two-year study, which will begin in January, nurses at Duke will evaluate the effectiveness of the InnerSense feeding tube sensor for preventing infant heat loss and providing additional information to physicians that could effect treatment decisions. It will be a randomized control trial of 160 infants, lead researcher Robin Knobel told MobiHealthNews in an email. The study group will use the tube sensor for their first 24 hours of life. Both groups will also have their temperature taken at the armpit (the standard of care) at admission and after 1, 4, and 8 hours.
"Low birth weight infants require stabilization procedures that make it difficult for nurses to assess their body temperature using thermometers or skin probes," Knobel said in a statement. "With this study, we hope to demonstrate how continuous, real-time temperature monitoring can provide clinicians with a wealth of information on the infant's body temperature, helping to prevent hypothermia and provide optimal care."
The care of infants is emerging as one of the key clinical use cases for remote temperature monitoring. In another example, Beijing-based Raiing is working with Boston’s Partners HealthCare to pilot Raiing’s smartphone-connected wireless thermometer, iThermonitor, at Massachusetts General Hospital. There, researchers are testing the temperature monitoring device on 25 children and adolescents with leukemia.