Pulse Oximetry Performance Comparison in Newborns

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.

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.