Investigating pulse oximetry accuracy in newborns with different skin colors
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
This study is testing if pulse oximeters give different oxygen level readings for newborns with darker skin compared to those with lighter skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 163 (estimated) |
| Ages | N/A to 10 Days |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT06063148 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether pulse oximeters overestimate oxygen levels in newborns with darker skin compared to those with lighter skin. Researchers will enroll 163 newborns in intensive care units, measuring both arterial oxygen saturation (SaO2) and pulse oximetry saturation (SpO2) simultaneously. The study will analyze how skin pigmentation, gestational age, and blood transfusions affect the accuracy of pulse oximetry readings. Data will be collected through routine blood samples and electronic health records to evaluate discrepancies in oxygen saturation readings based on skin color.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns under 10 days old admitted to an intensive care unit who have an arterial catheter or are undergoing arterial blood gas sampling.
Not a fit: Patients with abnormal hemoglobin levels or those for whom SpO2 cannot be measured in the same extremity as the arterial catheter may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in oxygen monitoring for newborns, particularly those with darker skin, enhancing patient care and outcomes.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated disparities in medical device accuracy based on skin pigmentation, suggesting potential for impactful findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California and 1 other locations
- UC Davis Health — Sacramento, California, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.