Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Masimo

Status: Terminated

Conditions: Regional Saturation of Oxygen (rSO2)

Treatments: Device: 510(k) cleared sensor; Device: Masimo O3 Neonatal Sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828487

RAMA0004

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than 10 kg
• Subjects less than or equal to 28 days old

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Neonatal Test group

Experimental group

Description:

Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.

Treatment:

Device: 510(k) cleared sensor

Device: Masimo O3 Neonatal Sensors