Pulse Oximetry Performance Comparison in Newborns

Medtronic

Status

Active, not recruiting

Conditions

Newborn

Birth, Preterm

Treatments

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

Device: LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter

Device: 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor

Study type

Observational

Funder types

Industry

Identifiers

NCT06637917

MDT24005PROLD

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

29+ weeks old

Volunteers

Accepts Healthy Volunteers

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.