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Study reveals pulse oximeters may overestimate oxygen in Darker-Skinned newborns

NCT ID NCT06063148

Knowledge-focused Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether pulse oximeters, which measure oxygen levels, give less accurate readings for newborns with darker skin. Researchers will compare oxygen readings from the device with actual blood oxygen levels in 163 babies of different skin tones. The goal is to find out if skin color affects accuracy, which could help improve care for all newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 163 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 10 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * \<26 weeks corrected gestational age (After May 2024, infants \<26 weeks corrected GA were excluded due to skin irritation with sensor removal, those enrolled earlier were included in the analysis) * 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.

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Conditions

The condition(s) this trial relates to.

skin pigmentation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulse oximetry Skin pigment

Contacts and locations

Locations

  • UC Davis Health

    Sacramento, California, 95817, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

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