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New baby oxygen sensor put to the test

NCT ID NCT05896267

Knowledge-focused Sponsor: Masimo Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new sensor (INVSENSOR00061) in 64 infants from full-term newborns up to 18 months old. The goal was to see how well it measures oxygen levels and heart rate compared to a standard sensor. The study did not treat any disease, just collected data to check the sensor's accuracy.

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

64 people

The number who actually took part.

Started

May 2023

Finished

Jun 2023

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.

Ages

37 weeks to 18 months

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: * • Subject is a full-term newborn (37 weeks) to 18 months of age. Exclusion Criteria: * • Subject has underdeveloped skin. * Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements. * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors. * Subject is not suitable for the investigation at the discretion of the Investigator.

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As listed by the trial registrant

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

SPO2

Contacts and locations

Locations

  • Bailony Pediatrics

    National City, California, 91950, United States

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