Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03828487
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Regional Saturation of Oxygen (rSO2)	Device: Masimo O3 Neonatal Sensors; Device: 510(k) cleared sensor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
• Actual Study Start Date: Dec 19, 2018
• Actual Primary Completion Date: Jun 14, 2019
• Actual Study Completion Date: Jun 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neonatal Test group Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.	Device: Masimo O3 Neonatal Sensors; Regional Oximetry sensor for Neonates; Device: 510(k) cleared sensor; Cleared Regional Oximetry sensor for Neonates

Outcome Measures

Primary Outcome Measures

1. Number of Participants With rSO2 Collected [Data collection period; alternating sensors every 5 minutes for up to 20 minutes.]

   In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 14, 2019

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03828487
• Other Study ID Numbers: RAMA0004
• First Posted: Feb 4, 2019
• Last Update Posted: Jun 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Arm/Group Title	Neonatal Test Group
Arm/Group Description	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates
Period Title: Overall Study
STARTED	8
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Neonatal Test Group
Arm/Group Description	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates
Overall Participants	7
Age (Count of Participants)
<=18 years	7 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 42.9%
Male	4 57.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 14.3%
White	5 71.4%
More than one race	0 0%
Unknown or Not Reported	1 14.3%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With rSO2 Collected
Description	In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
Time Frame	Data collection period; alternating sensors every 5 minutes for up to 20 minutes.

Outcome Measure Data

Analysis Population Description

Study was prematurely terminated. Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.

Arm/Group Title	Neonatal Test Group
Arm/Group Description	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates
Measure Participants	7
Count of Participants [Participants]	7 100%

Adverse Events

Time Frame	1 day
Arm/Group Title	Neonatal Test Group
Arm/Group Description	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates
All Cause Mortality
	Neonatal Test Group
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Neonatal Test Group
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Neonatal Test Group
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.