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.
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 newborns of varying degrees of light and dark skin to assess the impact of skin pigmentation on the accuracy of pulse oximetry. Data collection will occur during routine blood samples and will involve simultaneous measurement of oxygen saturation by pulse oximetry and additional data extraction from the EHR. The study consists of 4 main components: (1) Skin pigment classification (2) Race and ethnicity classification (3) SpO2 measurement collection (4) EMR data collection (including newborn screen hemoglobin type assessment and transfusion records). After adjusting for SaO2, the SaO2-SpO2 discrepancy will correlate with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The distribution of SaO2-SpO2 discrepancy will have more variance in the newborns with darker skin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
163
Participant will undergo at most 10 SpO2 measurements paired with at most 10 routine blood gas samples.
UC Davis Health
Sacramento, California, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Determine if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates.
Using a prospective cohort of 163 newborns, the investigators will calculate simultaneous SaO2-SpO2 discrepancy and correlate it with a measure of skin pigmentation (melanin index: Fitzpatrick Scale, Massey-Martin scale and ITA: individual Typology Angle) among neonates with and without hypoxemia.
Time frame: Through study completion, about 2 years
Determine the influence of packed red blood cell (PRBC) transfusion on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.
Many infants in the NICU setting are transfused PRBC with hemoglobin A, which shifts the oxygen-hemoglobin dissociation curve to the right. While the effect of this shift on pulse oximetry is studied, the combined impact of skin pigmentation and transfusion is not known. The investigators will test the hypothesis that PRBC transfusion increases the impact of skin pigmentation on SaO2- SpO2 discrepancy. The investigators will calculate the SaO2-SpO2 discrepancy and correlate it with the skin pigmentation measurement and frequency of PRBC transfusion.
Time frame: Through study completion, about 2 years
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