Skip to main content
OpenTrials
Completed

NCT Number: NCT06637917

Pulse Oximetry Performance Comparison in Newborns

The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Newborn Birth, Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

29 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System

Device

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-Oximeter

Device

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 Monitor

Device

Market-released ECG monitoring system

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.