Pulse Oximetry Accuracy for Newborns with Different Skin Pigmentations

(Neo-PODS Trial)

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Abnormal hemoglobin, SpO2 measurement issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

163 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Enrolled Participant in the clinical trial Pulse Oximetry Accuracy for Newborns with Different Skin Pigmentations?

Research shows that pulse oximeters, which measure oxygen levels in the blood, can sometimes be less accurate for people with darker skin. However, one study found no significant difference in accuracy based on skin color in infants with low oxygen levels, suggesting that improvements in technology or methods may help address these discrepancies. ^{1 2 3 4 5}

Is pulse oximetry safe for newborns with different skin pigmentations?

Pulse oximetry is generally considered safe for newborns, but there are concerns about its accuracy in those with darker skin. Efforts are being made to improve the accuracy and reduce any potential bias in these devices. ^{1 3 4 5 6}

How does this treatment differ from other treatments for newborns with different skin pigmentations?

This study focuses on the accuracy of pulse oximetry (a device that measures oxygen levels in the blood) in newborns with different skin colors, which is unique because it addresses potential racial discrepancies in measurement accuracy, unlike other treatments that may not consider skin pigmentation. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for newborns less than 10 days old in intensive care with an arterial catheter or those undergoing blood gas sampling. It's not for babies with abnormal hemoglobin levels or when SpO2 can't be measured in the same limb as the catheter.

Inclusion Criteria

My newborn is less than 10 days old and in intensive care.

I have an arterial catheter or have had an arterial blood gas test.

Exclusion Criteria

Your oxygen level cannot be measured in the same arm where the arterial catheter is placed.

My blood test shows abnormal hemoglobin levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Simultaneous measurement of SpO2 and SaO2 during routine blood samples, along with skin pigment and race classification

2 years

Up to 10 measurements per participant

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

Treatment Details

Interventions

• Enrolled Participant

Trial Overview The study investigates if pulse oximeters inaccurately read oxygen levels (SaO2-SpO2 discrepancy) due to skin pigmentation differences in newborns, considering factors like gestational age and red blood cell transfusions.

Participant Groups

Group I: Enrolled Participant Experimental Treatment 1 Intervention

During routine arterial blood gas sampling, a coordinator will measure SpO2 from a similar extremity. SpO2 data will be recorded using Masimo Radical-7 oximeters. To minimize ambient light interference or optical cross talk from other SpO2 sensors, all the SpO2 sensors will be fully shielded with cloth wraps provided by Masimo. Each enrolled infant will undergo simultaneous blood gas sampling and SpO2 measurement for each routine blood gas collected. Up to a total of 10 SpO2 measurements will be collected, paired with 10 blood gas samples collected as part of routine care, though We anticipate about 3 paired samples (SaO2 and SpO2) per enrolled infant.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Pulse oximeters have been found to be less accurate in patients with darker skin, which can lead to missed diagnoses of hypoxemia, highlighting a significant safety concern in their use.

The authors propose five key areas for research and regulatory changes to improve oximeter accuracy, including diversifying study subject pools and enhancing transparency in performance reporting, which could help ensure safer and more effective use of these devices across all skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Okunlola, OE., Lipnick, MS., Batchelder, PB., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Newborn Pulse Oximetry Screening at a Community Hospital: An 8-Year Experience. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Racial discrepancy in pulse oximeter accuracy in preterm infants. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Skin Pigmentation on the Accuracy of Pulse Oximetry in Infants with Hypoxemia. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of skin pigmentation on pulse oximeter accuracy at low saturation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ethnic disparities in publicly-available pulse oximetry databases. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. [2008]