Pulse Oximetry Performance Comparison in Newborns
1 other identifier
observational
120
1 country
3
Brief Summary
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2024
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedStudy Start
First participant enrolled
September 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2025
CompletedMarch 12, 2026
September 1, 2025
1 year
August 23, 2024
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
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).
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.
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.
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
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.
Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Study Arms (1)
Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
Interventions
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.
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.
Market-released ECG monitoring system
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (3)
Cedars-Sinai
Los Angeles, California, 90048, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
October 15, 2024
Study Start
September 10, 2024
Primary Completion
September 18, 2025
Study Completion
September 18, 2025
Last Updated
March 12, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share