Pulse Oximetry Performance Comparison in Newborns

Description

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

Conditions

Newborn, Birth, Preterm

Study Overview

Study Details

Study overview

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

Pulse Oximetry Performance Comparison in Newborns

Pulse Oximetry Performance Comparison in Newborns

Condition
Newborn
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63130

Winston-Salem

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

29 Weeks to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Medtronic - MITG,

Study Record Dates

2025-02