Trial Outcomes & Findings for Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates (NCT NCT03828487)

Last Updated: 2021-06-07

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Data collection period; alternating sensors every 5 minutes for up to 20 minutes.

Results posted on

2021-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Neonatal Test Group 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 Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neonatal Test Group 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 Study Physician Decision	1

Baseline Characteristics

Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neonatal Test Group n=7 Participants 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
Age, Categorical <=18 years	7 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.

Population: 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.

Outcome measures

Outcome measures
Measure	Neonatal Test Group n=7 Participants 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
Number of Participants With rSO2 Collected	7 Participants

Adverse Events

Neonatal Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vikram Ramakanth

Masimo Corporation

Phone: 949-297-7416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60