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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the accuracy of pulse oximeters for newborns with varying skin tones. Researchers aim to determine if these devices, which measure blood oxygen levels, provide different readings for newborns with lighter or darker skin. The trial seeks to understand whether factors such as skin color, gestational age, and blood transfusions influence the readings. Newborns under 10 days old in intensive care, who undergo arterial blood draws, are suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to significant research that could enhance medical care for newborns of all skin tones.

Will I have to stop taking my current medications?

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

What prior data suggests that this pulse oximetry method is safe for newborns?

Past studies have found pulse oximeters to be generally safe for everyone, regardless of skin color. However, research shows potential measurement errors, indicating that pulse oximeters might not always provide accurate readings for people with darker skin. Some studies suggest these devices can sometimes display higher oxygen levels than actually present in darker-skinned individuals.

Despite this inaccuracy, pulse oximeters remain safe. The main concern is obtaining precise readings, not causing harm. Ongoing research aims to better understand this issue and improve accuracy. Overall, pulse oximeters are considered safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the accuracy of pulse oximetry readings for newborns with different skin pigmentations. Unlike traditional pulse oximeters that might not account for variations in skin color, this study uses Masimo Radical-7 oximeters, enhanced with cloth wraps to reduce interference from ambient light. This could lead to more reliable monitoring of oxygen levels in newborns, ensuring they receive the best possible care regardless of their skin pigmentation. By refining these measurements, healthcare providers can deliver more precise and equitable treatment for all infants.

What evidence suggests that pulse oximetry is effective for measuring oxygenation in newborns with different skin pigmentations?

This clinical trial does not test a new drug or treatment. Instead, it examines the effectiveness of pulse oximeters for newborns with varying skin colors. Research has shown that these devices, which measure blood oxygen levels, might not always provide accurate readings for individuals with darker skin. They sometimes display higher oxygen levels than are present, potentially affecting proper care. The study aims to determine if this issue occurs in newborns and whether factors like skin color or blood transfusions affect accuracy. The goal is to ensure accurate oxygen readings for all newborns, regardless of skin color.

Are You a Good Fit for This Trial?

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

My blood test shows abnormal hemoglobin levels.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5328979/

The Effect of Skin Pigmentation on the Accuracy of Pulse ... We did not find evidence of systematic bias in pulse oximetry measurement based on skin pigmentation in infants with hypoxemia.

2. apsf.org apsf.org/article/apsf-statement-on-pulse-oximetry-and-skin-tone/

APSF Statement on Pulse Oximetry and Skin Tone The preponderance of evidence supports the conclusion that there is a measurement bias in pulse oximeter measurements due to skin tone such that pulse oximeter ...

3. fda.gov fda.gov/media/175828/download

FDA Executive Summary Performance Evaluation of Pulse ... measurement of skin pigmentation, capture simultaneous measurement of SaO2 and SpO2 paired data, and systematically collect data on ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526054224000502

Pulse oximetry in patients with pigmented skin Research has suggested that pulse oximetry is less accurate in patients with darker skin. This led the US Food and Drug Administration agency (FDA) to issue a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06529575

Evaluating the Relationship Between Skin Color and Pulse ... This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical ...