|The InnerSense Esophageal Temperature Probe--Courtesy of Philips|
Practitioners often complain of about a lack of child-friendly devices due to the prevalence of rare diseases, which creates a small market size. Other challenges include children's size and frequent growth spurts. A lack of age-appropriate devices has led to complications in the infant temperature monitoring space. To counter this, Philips ($PHG) will use its InnerSense Esophageal Temperature Probe to monitor the core temperature of underweight infants in collaboration with the Duke University School of Nursing.
The device measures the temperature in the esophagus--Philips says esophageal temperature is a more accurate and reliable indicator than rectal, armpit or skin temperatures. The catheter also contains a lumen, or hole, enabling a miniature feeding tube appropriate for infants.
The two organizations say that infants born under 1,500 grams (a little more than 3 pounds) suffer from hypothermia after birth. ''Monitoring core temperature is critical for caregivers in helping to reduce mortality and morbidity among infants," said Michael Mancuso, the CEO of Philips Healthcare's Patient Care and Monitoring Solutions unit, 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.''
Historically, there has been a shortage of accurate and comfortable temperature monitors for underweight infants, such as preemies, the release says. "Low birth weight infants require stabilization procedures that make it difficult for nurses to assess their body temperature using thermometers or skin probes,'' said nurse and lead researcher Robin Knobel of Duke University School of Nursing 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 condition, helping to prevent hypothermia and provide optimal care.''
The study will monitor infant temperature with InnerSense for a little patient's first 24 hours. The Philips-Duke team will publish a paper on the degree to which monitoring helps clinicians make better decisions and whether it can help prevent excessive heat loss in infants. Enrollment in the two-year study begins in January 2015.
The collaboration should delight the FDA, which this year held a public hearing on the topic, funded pediatric device consortia and issued a final rule requiring companies to include information on pediatric subpopulations that suffer from the disease or condition that their device is intended to treat.
- read the release