Status:
RECRUITING
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Skin Pigment
Pulse Oximetry
Eligibility:
All Genders
Up to 10 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to determine if pulse oximeters show an SaO2-SpO2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newbor...
Detailed Description
Investigators will use a multicenter prospective cohort approach to measure SpO2 and SaO2 simultaneously in newborns of varying degrees of light and dark skin. The investigators will enroll 163 newbor...
Eligibility Criteria
Inclusion
- Newborns postnatal age \< 10 days admitted to intensive care unit
- Presence of arterial catheter or undergoing arterial stick blood gas sampling
Exclusion
- Presence of abnormal hemoglobin (including methemoglobin \> 3%) - likely to only be known after enrolled and the blood gas is obtained
- Those in whom SpO2 cannot be measured in the same extremity as the arterial catheter.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT06063148
Start Date
April 1 2022
End Date
January 1 2026
Last Update
April 3 2025
Active Locations (2)
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1
UC Davis Health
Sacramento, California, United States, 95817
2
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216