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New Light-Based sensors could spot hidden heart defects in newborns

NCT ID NCT05880576

Knowledge-focused Sponsor: Boston 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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether combining standard monitoring tools with new light-based sensors can better detect a dangerous narrowing of the aorta in newborns. Infants under one month old with suspected aortic arch obstruction will be monitored using resonance Raman spectroscopy, pulse oximetry, blood pressure, and near-infrared spectroscopy. The goal is to improve early diagnosis and prevent life-threatening complications.

What this could mean

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

What this could lead to
If successful, this could lead to better, non-invasive ways to detect dangerous heart blockages in newborns, potentially saving lives by enabling earlier treatment.
What could go wrong
This is an early-stage observational study with only 60 infants, so results may not apply to all newborns. The new monitoring tools may not prove more effective than current methods.

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 60 people

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

Started

Oct 2023

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.

Who is studied

Infants with prenatal or postnatal echocardiographic findings concerning for or diagnostic of aortic arch obstruction admitted to the BCH CICU.

Ages

0 to 60 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: * Infants with echocardiography-based possible or definite aortic arch obstruction and \<1 month postnatal age admitted to the CICU * Clinical team assent to approach family, (3) parent/guardian informed consent. Inclusion criteria includes infants with concurrent other congenital heart disease, or simple Coarctation of the aorta or arch hypoplasia Exclusion Criteria: * Known carrier status for resistant organisms. Resistant organisms are defined as MRSA and VRE.

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Conditions

The condition(s) this trial relates to.

aorta coarctation aortic arch defects

As listed by the trial registrant

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

Aortic arch obstruction Coarctation of the aorta

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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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