Pulse Oximetry Performance Comparison in Newborns

Active, not recruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

September 10, 2024

Primary Completion Date

September 18, 2025

Study Completion Date

November 30, 2025

Conditions
NewbornBirth, 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

Trial Locations (3)

27157

Atrium Health Wake Forest Baptist, Winston-Salem

63130

Washington University in St. Louis, St Louis

90048

Cedars-Sinai, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY

NCT06637917 - Pulse Oximetry Performance Comparison in Newborns | Biotech Hunter | Biotech Hunter