Pulse Oximetry Performance Comparison in Newborns

Recruiting

• Conditions: Newborn; Birth, Preterm

• Registration Number: NCT06637917
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-23
• Study Start: 2024-09-10
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG).	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.

Secondary Outcome Measures

Name	Time	Method
To evaluate instances of false bradycardia.	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate instances of false bradycardia requiring emergency medical treatment.	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To evaluate variability in PR between the two PO sensors	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare the number of repositions and replacements required for the two PO sensors during monitoring.	Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.

Trial Locations

Locations (3)

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States