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Could a forehead sensor replace needle sticks for hemoglobin checks in kids?

NCT ID NCT07706140

Diagnosis Sponsor: Boston Children's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study enrolls children and young adults scheduled for heart surgery or catheterization under general anesthesia. Researchers place a forehead sensor that measures tissue oxygen levels and use an algorithm to estimate blood hemoglobin. The goal is to see if this noninvasive method, already FDA-cleared for adults, works accurately in pediatric patients.

What this could mean

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

Active substance
noninvasive hemoglobin monitoring using a near-infrared spectroscopy (NIRS)-based tissue oximetry system
What this could lead to
If successful, this could provide a needle-free way to monitor hemoglobin levels in children during heart procedures, reducing the need for blood draws.
What could go wrong
The algorithm was designed for adults and may not work as well in children. The study is small and observational, so 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 2027

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

The study population includes pediatric and adolescent patients under 21 years of age who are scheduled to undergo elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia at Boston Children's Hospital. All participants will have an arterial catheter placed as part of routine clinical care and will receive standard intraoperative physiologic monitoring.

Ages

0 days to 21 years

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: 1. Age less than 21 years at the time of enrollment. 2. Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia. 3. Placement of an arterial catheter as part of routine clinical care for the procedure. Exclusion Criteria: 1. Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality. 2. Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Cerebral oxygenation Congenital heart disease Evaluation of hemoglobin using non invasive monitors Hemoglobin Validation of the algorithm used to estimate hemoglobin from the cerebral oxygen measurements over time

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

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

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