Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2019-06-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Regional Saturation of Oxygen (rSO2)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neonatal Test group

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

Group Type EXPERIMENTAL

Masimo O3 Neonatal Sensors

Intervention Type DEVICE

Regional Oximetry sensor for Neonates

510(k) cleared sensor

Intervention Type DEVICE

Cleared Regional Oximetry sensor for Neonates

Interventions

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Masimo O3 Neonatal Sensors

Regional Oximetry sensor for Neonates

Intervention Type DEVICE

510(k) cleared sensor

Cleared Regional Oximetry sensor for Neonates

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes