Pulse Oximetry Performance Comparison in Newborns

Completed

Conditions studied: Newborn, Birth, Preterm

In brief

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

Key facts

Study ID

NCT06637917

Run by

Medtronic - MITG

People needed

120

Starts

2024-09-10

Expected to finish

2025-09-18

Last updated by the study team

2026-03-12

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai — Los Angeles, California, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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