Status:
TERMINATED
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
Lead Sponsor:
Masimo Corporation
Conditions:
Regional Saturation of Oxygen (rSO2)
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Less than 10 kg
- Subjects less than or equal to 28 days old
Exclusion
- Underdeveloped skin at sites of sensor placement
- Jaundice or bilirubin levels out of normal range
- Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study
- Subject deemed not eligible based on Principal Investigator's judgment
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03828487
Start Date
December 19 2018
End Date
June 14 2019
Last Update
June 7 2021
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305