Pulse Oximetry Accuracy for Newborns with Different Skin Pigmentations
(Neo-PODS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

No Placebo Group

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.

Research Team

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.

Treatment Details

Interventions

Enrolled Participant (Device)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Enrolled ParticipantExperimental Treatment1 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.