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Which oxygen monitor works best for newborns? study finds out.

NCT ID NCT06637917

Knowledge-focused Sponsor: Medtronic - MITG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two different pulse oximeters (devices that measure oxygen levels and heart rate) on 120 newborns to see which one worked better. The goal was to compare how quickly and accurately each device got a stable heart rate reading compared to a standard ECG. The results could help hospitals choose the best monitor for 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.

Participants

120 people

The number who actually took part.

Started

Sep 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Up to 120 newborns will be selected for this study. A variety of subjects will be targeted for inclusion representing differing stages of development and environments

Ages

29 weeks and older

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: * Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed. * Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring. * Subject is ≥ 29 weeks gestational age. * Subject can accommodate multiple sensors. Exclusion Criteria: * Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded. * Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare. * Currently participating in any other study expected to confound study results in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Birth, preterm Newborn

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Cedars-Sinai

    Los Angeles, California, 90048, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.