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Belly sensor could revolutionize oxygen monitoring for babies with heart defects

NCT ID NCT07686341

Knowledge-focused Sponsor: Le Bonheur Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests a new pulse oximeter worn on the abdomen, designed to measure oxygen levels in infants with congenital heart disease. Researchers compare its accuracy against standard fingertip monitors and direct blood measurements. The device also includes features to reduce errors from motion and different skin tones. If successful, it could provide a more reliable and comfortable way to monitor oxygen in hospitalized children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abdominal pulse oximeter device
What this could lead to
If accurate, this device could offer a more reliable way to monitor oxygen levels in children, especially those with darker skin or who move a lot.
What could go wrong
This is a small, early validation study in 100 children. The device may not prove accurate enough, and results may not apply to all pediatric patients.

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

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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.

Who is studied

Eligible infants hospitalized in the intensive care unit (PICU, PCVICU,NICU) who have already had an arterial line placed and on continuous pulse oximetry monitoring will be considered for enrollment and will be identified and approached for participation during their admission.

Ages

0 to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study * Admitted to an intensive care unit. (Not applicable for outpatient cohort) * Arterial line in place as standard of care (Not applicable for outpatient cohort) * Informed consent provided by parent or LAR. Exclusion Criteria: * Open Sternum * Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection) * Known allergy or sensitivity to adhesives or materials used in the sensor * Excessive movement or irritability that precludes safe and effective placement of the sensor * Parent or legal guardian unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

congenital heart disease univentricular cardiopathy univentricular heart

As listed by the trial registrant

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

CHD - congenital heart disease Single ventricle heart disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Le Bonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

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