Pulse Oximetry Performance Comparison in Newborns

Launched by MEDTRONIC - MITG · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Pulse Oximetry Performance Comparison in Newborns," aims to compare how well two different pulse oximeters work in measuring the heart rate and oxygen levels in newborns. Pulse oximeters are devices that help monitor how well a baby's body is getting oxygen. The study is currently looking for participants, specifically newborns who are at least 29 weeks old and can handle having multiple sensors attached to them.

To be eligible for this study, parents or legal guardians must agree to provide consent before any procedures begin. It's important that the newborn doesn’t have any serious health conditions that could interfere with the accuracy of the pulse oximeter readings. If a baby participates, they can expect to be monitored in the delivery room for a duration that usually aligns with standard heart monitoring practices. This study is an opportunity to help improve the technology used in monitoring the health of newborns.

Gender

ALL

Eligibility criteria

• 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.