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New ultrasound test may detect brain damage in newborns

NCT ID NCT07322315

Diagnosis Sponsor: Kafrelsheikh University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether a special ultrasound of the brain's blood vessels can accurately diagnose brain injuries in newborns. Researchers will use transcranial Doppler ultrasound on 60 high-risk babies to see how well it detects problems. If it works, it could offer a safer, faster way to check for brain injuries in the tiniest patients.

What this could mean

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

Active substance
Transcranial Doppler ultrasound device
What this could lead to
If successful, this could provide a quick, non-invasive way to detect brain injuries in newborns, potentially speeding up treatment.
What could go wrong
This is a small, early-stage study with only 60 participants. The ultrasound may not be accurate enough to replace standard diagnostic 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

Jan 2026

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

This prospective observational study will be carried out on 60 neonates admitted to Kafr- Elsheikh University Hospitals over a period of one year starting from approval of the Ethics Committee of Kafr- Elsheikh, Faculty of Medicine and parents of all the included patients will provide written informed consent.

Ages

Up to 37 weeks

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: * Both sexes. * High-risk neonates with any of the following: * Critically ill neonates. * Neonatal sepsis. * Neonatal encephalopathy includes hypoxic-ischemic encephalopathy. * Respiratory distress. * Neonatal seizures. * Birth asphyxia. * Signs and or symptoms of central nervous system disorders like microcephaly, macrocephaly, hypotonia, unexplained poor feeding, * Neonates born out of traumatic/instrumental labor. * Suspected metabolic disturbances. * Neonates with low APGAR score (\<7). * Neonates with low birth weight (\<2.5 kg). Exclusion Criteria: * Congenital malformations. * Genetic metabolic diseases or other severe complications. * Severe intrauterine infection.

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Conditions

The condition(s) this trial relates to.

head injury

As listed by the trial registrant

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

Diagnostic value Neonatal craniocerebral injuries Transcranial doppler ultrasound

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

  • Kafrelsheikh University

    RECRUITING

    Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

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