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

Q: Are participants currently being enrolled for this scientific experiment?

<p>According to the data found on clinicaltrials.gov, this particular medical study is currently accepting participants and was initially posted in April 2022 with a most recent update from September 2023.</p>

Q: What is the current sample size of this trial's participants?

<p>Affirmative. Clinicaltrials.gov confirms that this research study, which was initially released on April 1st 2022, is currently in search of participants. A total of 163 people must be enrolled from two separate facilities.</p>

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborns postnatal age < 10 days admitted to intensive care unit

Presence of arterial catheter or undergoing arterial stick blood gas sampling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, about 2 years

Awards & highlights

Neo-PODS Trial Summary

This trial studies how skin pigmentation affects the accuracy of pulse oximeters in measuring oxygen levels in newborns.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves standard monitoring procedures without new medications, there are no direct side effects from interventions being tested.

Neo-PODS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Neo-PODS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, about 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, about 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, about 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates.

Determine the influence of gestational age on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.

Determine the influence of packed red blood cell (PRBC) transfusion on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.

Neo-PODS Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,356 Total Patients Enrolled

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

1,965 Previous Clinical Trials

2,672,634 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled for this scientific experiment?

"According to the data found on clinicaltrials.gov, this particular medical study is currently accepting participants and was initially posted in April 2022 with a most recent update from September 2023."

Answered by AI

What is the current sample size of this trial's participants?

"Affirmative. Clinicaltrials.gov confirms that this research study, which was initially released on April 1st 2022, is currently in search of participants. A total of 163 people must be enrolled from two separate facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

Heather Siefkes 2022. "Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063148.