NewbornNCT06637917
Pulse Oximetry Performance Comparison in Newborns
An observational study of Newborn and Birth, Preterm, run by Medtronic - MITG at 3 sites in United States.
Trial summary
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns. Read more about this study
- Who is it for?
- Ages 29 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Newborn, Birth, Preterm
- What is being tested?
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter and 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2024to 18 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 29 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Up to 120 newborns will be selected for this study. A variety of subjects will be targeted for inclusion representing differing stages of development and environments
Who may be able to join
- Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
- Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
- Subject is ≥ 29 weeks gestational age.
- Subject can accommodate multiple sensors.
Who cannot join
- Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded.
- Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
- Currently participating in any other study expected to confound study results in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cedars-Sinai
Los Angeles, California, 90048
Washington University in St. Louis
St Louis, Missouri, 63130
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
- Conditions
- Newborn, Birth, Preterm
- Being tested
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring SystemDevice
The Nellcor™ N-600x Pulse Oximetry System with N-600X Pulse Oximeter and Nellcor™ Sensors and Cables with OxiMax technology is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and PR. The N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-OximeterDevice
The Masimo Rad-97™ and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin, PR, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or acoustic respiratory rate (RRa). The Masimo Rad-97™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97™ and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97™ and accessories for functional oxygen saturation of arterial hemoglobin and PR to multi-parameter devices for the display on those devices.
1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient MonitorDevice
Market-released ECG monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Newborn | A variety of subjects will be targeted for inclusion representing differing stages of development and environments Receives: Device: OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System; Device: LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter; Device: 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG).
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Secondary outcomes (4)
To evaluate instances of false bradycardia.
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate instances of false bradycardia requiring emergency medical treatment.
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate variability in PR between the two PO sensors
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare the number of repositions and replacements required for the two PO sensors during monitoring.
Measured: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Sep 2024
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637917
- Sponsor's protocol ID
- MDT24005PROLD
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximetry Performance Comparison in Newborns
- ClinicalTrials.gov ID
- NCT06637917
- Acronym / sponsor ID
- MDT24005PROLD
- Conditions
- Newborn, Birth, Preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn | – | Device: OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, Device: LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, Device: 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient MonitorA variety of subjects will be targeted for inclusion representing differing stages of development and environments |
Who may qualify
- Ages
- 29 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 120 newborns will be selected for this study. A variety of subjects will be targeted for inclusion representing differing stages of development and environments
Key inclusion criteria (4 listed)
- Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
- Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
- Subject is ≥ 29 weeks gestational age.
- Subject can accommodate multiple sensors.
Key exclusion criteria (3 listed)
- Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded.
- Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
- Currently participating in any other study expected to confound study results in the opinion of the investigator.
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 |
|---|---|---|
| OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring SystemThe Nellcor™ N-600x Pulse Oximetry System with N-600X Pulse Oximeter and Nellcor™ Sensors and Cables with OxiMax technology is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and PR. The N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. | Device | Newborn |
| LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-OximeterThe Masimo Rad-97™ and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin, PR, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or acoustic respiratory rate (RRa). The Masimo Rad-97™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97™ and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97™ and accessories for functional oxygen saturation of arterial hemoglobin and PR to multi-parameter devices for the display on those devices. | Device | Newborn |
| 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient MonitorMarket-released ECG monitoring system | Device | Newborn |
Primary outcome
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG).
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
4 secondary outcomes
To evaluate instances of false bradycardia.
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate instances of false bradycardia requiring emergency medical treatment.
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate variability in PR between the two PO sensors
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare the number of repositions and replacements required for the two PO sensors during monitoring.
Time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn and Birth, Preterm, run by Medtronic - MITG at 3 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO). (time frame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.). The study lists 2 primary outcomes in all. 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 12 Mar 2026.