NCT03828487

Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

Summary

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

Conditions

• Regional Saturation of Oxygen (rSO2)

Interventions

Type	Name	Description
DEVICE	Masimo O3 Neonatal Sensors	Regional Oximetry sensor for Neonates
DEVICE	510(k) cleared sensor	Cleared Regional Oximetry sensor for Neonates

Timeline

• Start date: 2018-12-19
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2019-02-04
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study