About this trial
The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring
undergoing monitoring with the INVOS wired NIRS system.
Disqualifiers
Infants with a skin abnormality that would potentially increase the risk of injury,
Patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.
Trial design
Single group
Treatments tested in this trial
Wireless NIRS
DeviceWireless NIRS applied to participant forehead.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.
Secondary outcomes
Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device.
Provide a a custom study questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device. The questionnaire includes Likert-scale items, multiple-choice questions, and open-ended responses evaluating usability, perceived safety, accuracy, comfort, and acceptability. Responses will be summarized descriptively by questionnaire item.
Sponsors and contacts
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