Clinical trial NCT06063148: Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Official title: Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Pigment
Pulse Oximetry
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-02
Enrollment: 163
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Newborns postnatal age \< 10 days admitted to intensive care unit
* Presence of arterial catheter or undergoing arterial stick blood gas sampling

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Determine if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates.
timeFrame: Through study completion, about 2 years
measure: Determine the influence of gestational age on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.
timeFrame: Through study completion, about 2 years
measure: Determine the influence of packed red blood cell (PRBC) transfusion on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.
timeFrame: Through study completion, about 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References: