Evaluation of a Wireless Near-Infrared Spectroscopy Device Compared to Standard Wired NIRS in Newborns in the NICU

What this Trial Is About

Researchers are evaluating a wireless near-infrared spectroscopy NIRS device compared to the standard wired NIRS system in newborns admitted to the neonatal intensive care unit NICU. The study aims to compare the oxygen saturation data collected by the wireless device to the gold-standard wired sensor in infants with conditions such as hypoxic-ischemic encephalopathy, congenital heart disease, hemorrhagic stroke, or cerebral aneurysm. This research is conducted by the McGill University Health Centre to assess the new wireless technology in a clinical setting. The wireless NIRS sensor will be placed on the infants forehead directly beneath the standard wired INVOS sensor. It will remain in place for four consecutive hours over two consecutive days, with nursing staff removing sensors during routine skin checks to reduce pressure sore risks. The research team will document the times and conditions each time the wireless sensor is removed and reapplied to correlate signal disconnections with sensor care activities. Participants will be monitored using both wireless and wired sensors simultaneously while vital signs such as oxygen saturation SpO2 and heart rate HR are also recorded using the standard Philips IntelliVue MX800 system. The study will collect data over six months, including heart rate variability comparisons and questionnaires to gather feedback from clinicians and parents or guardians about the wireless device experience. Safety and skin condition assessments will be regularly performed throughout the monitoring period.

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit