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Pulse Oximetry Performance Comparison in Newborns

NCT06637917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-03-12

No results posted yet for this study

Summary

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

Interventions

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

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Eligibility

Min Age
29 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2025-09-18
Completion
2025-09-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06637917 on ClinicalTrials.gov