Regional Saturation of Oxygen (rSO2)NCT03828487
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
A study testing Masimo O3 Neonatal Sensors and 510(k) cleared sensor in people with Regional Saturation of Oxygen (rSO2), run by Masimo Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Regional Saturation of Oxygen (rSO2)
- What is being tested?
- Masimo O3 Neonatal Sensors and 510(k) cleared sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Less than 10 kg
- Subjects less than or equal to 28 days old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
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.
- Conditions
- Regional Saturation of Oxygen (rSO2)
- Being tested
- Masimo O3 Neonatal Sensors, 510(k) cleared sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo O3 Neonatal SensorsDevice
Regional Oximetry sensor for Neonates
510(k) cleared sensorDevice
Cleared Regional Oximetry sensor for Neonates
| Study group | Role | What they receive |
|---|---|---|
| Neonatal Test group | Experimental | Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Receives: Device: Masimo O3 Neonatal Sensors; Device: 510(k) cleared sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With rSO2 Collected
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.
Measured: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start19 Dec 2018
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Why it stopped: Sponsor terminated study due to project timeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Regional Saturation of Oxygen (rSO2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828487
- Sponsor's protocol ID
- RAMA0004
- Status last verified
- May 2021
- First submitted
- 10 Jan 2019
- Last updated
- 7 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
- ClinicalTrials.gov ID
- NCT03828487
- Acronym / sponsor ID
- RAMA0004
- Conditions
- Regional Saturation of Oxygen (rSO2)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study due to project timeline.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal Test group | Experimental | Device: Masimo O3 Neonatal Sensors, Device: 510(k) cleared sensorSubjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Less than 10 kg
- Subjects less than or equal to 28 days old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo O3 Neonatal SensorsRegional Oximetry sensor for Neonates | Device | Neonatal Test group |
| 510(k) cleared sensorCleared Regional Oximetry sensor for Neonates | Device | Neonatal Test group |
Primary outcome
Number of Participants With rSO2 Collected
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo O3 Neonatal Sensors and 510(k) cleared sensor in people with Regional Saturation of Oxygen (rSO2), run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With rSO2 Collected (time frame: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.