Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Running, not enrolling · Not applicable
Conditions studied: Skin Pigment, Pulse Oximetry
In brief
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 newborns with darker skin. The main questions it aims to answer is if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on SaO2-SpO2 discrepancy, and if packed red blood cell (PRBC) transfusion has an influence on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. Researchers will compare SaO2 and SpO2 values in neonates of various skin pigmentation.
Key facts
- Study ID
- NCT06063148
- Run by
- University of California, Davis
- People needed
- 163
- Starts
- 2022-04-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Newborns postnatal age < 10 days admitted to intensive care unit
- Presence of arterial catheter or undergoing arterial stick blood gas sampling
You may not qualify if…
- <26 weeks corrected gestational age (After May 2024, infants <26 weeks corrected GA were excluded due to skin irritation with sensor removal, those enrolled earlier were included in the analysis)
- 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.
Where it is running
- UC Davis Health — Sacramento, California, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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