Pulse Oximetry Performance Comparison in Newborns

March 10, 2026 updated by: Medtronic - MITG
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University in St. Louis
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
Device: OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System
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.
Device: LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter
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.
Device: 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
Market-released ECG monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Actual)

September 18, 2025

Study Completion (Actual)

September 18, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT24005PROLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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