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Tiny probe could give doctors a window into infant brains

NCT ID NCT06646250

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new, lightweight ultrasound device called NeoDoppler that can be gently placed on a newborn's soft spot (fontanelle) to continuously measure blood flow in the brain. Researchers will enroll 180 preterm and full-term infants, including those with conditions like sepsis, stroke, or heart defects. The goal is to see if the device provides reliable, high-quality measurements that could help doctors monitor brain health in real time.

What this could mean

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

Active substance
NeoDoppler device
What this could lead to
If successful, this could provide doctors with a better, non-invasive way to continuously monitor brain blood flow in fragile newborns, potentially improving care for conditions like stroke or sepsis.
What could go wrong
This is an early-stage device study focused on measurement quality, not treatment outcomes. The device may not prove reliable enough for routine clinical use, and results may not apply to all infant populations.

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 180 people

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

Started

Oct 2024

Expected to finish

Dec 2029

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

Neonates/infants born prematurely or at term that are healthy or that have a medical contentions or that are in need of procedures that are admitted to the maternal ward or neonatal intensive care at St. Olavs Hospital in Trondheim, Norway.

Ages

0 minutes to 12 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: * Open fontanelle * Healthy preterm or term born neonates * Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection/sepsis/meningitis * Neonates in need of procedures Exclusion Criteria: * Caregivers not understanding/speaking Norwegian or English * Caregivers not giving their consent

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Conditions

The condition(s) this trial relates to.

Asphyxia congenital heart disease infectious disease infectious disease with sepsis meningitis patent ductus arteriosus perinatal asphyxia Premature Birth pulmonary hypertension Sepsis stroke disorder

As listed by the trial registrant

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

Asphyxia Congenital heart disease Patent ductus arteriosus Preterm Pulmonary hypertension Sepsis Stroke

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

  • Children's clinic, St. Olavs University Hospital

    RECRUITING

    Trondheim, 7030, Norway

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