NCT06063148

Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 10 Days
• Healthy volunteers: Accepted

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.

Conditions

• Skin Pigment
• Pulse Oximetry

Interventions

Type	Name	Description
DEVICE	Enrolled Participant	Participant will undergo at most 10 SpO2 measurements paired with at most 10 routine blood gas samples.

Timeline

• Start date: 2022-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-10-02
• Last updated: 2026-02-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study