Nellcor Vs. Masimo Pulse Oximetry Performance Comparison in Newborns

What is the Purpose of this Study?

The purpose of this study is to compare heart rate and oxygen saturation performance between 2 pulse oximeters (Nellcor and Masimo, both approved by the U.S. Food and Drug Administration) in newborns. Pulse oximeters are devices that measure oxygen saturation in the blood. Each of these devices will have a sensor that attaches to the child’s foot. Participants will be children whose heart rate and oxygen saturation levels need monitoring. Procedures include collecting demographic and medical information about the child and mother, applying 2 pulse oximeters to the child’s feet after delivery, and monitoring the child’s heart activity using an electrocardiogram.


Eligibility

  • * 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.
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Where can I participate?

Beverly : Robert Marker

More about this Clinical Trial

What is the full name of this clinical trial?

Nellcor vs Masimo Pulse Oximetry Performance Comparison in Newborns

Study Details
Disease Type/Condition

Other

Principal Investigator

Biniwale, Manoj

Age Group

Children

Phase

N/A

IRB Number

STUDY00003715

ClinicalTrials.gov ID

NCT06637917

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Robert Marker

Email
Robert.Marker@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Biniwale, Manoj

Age Group

Children

Phase

N/A

IRB Number

MDT24005PROLD

ClinicalTrials.gov ID

NCT06637917

Key Eligibility
ClinicalTrials.gov

Contact
Name

Robert Marker

Email
Robert.Marker@cshs.org