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New study aims to catch brain damage in babies after heart surgery

NCT ID NCT07424976

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study follows 30 infants with congenital heart disease who need heart surgery. Researchers will use blood tests, EEG brain wave monitoring, and MRI scans to look for signs of brain injury. The goal is to find better ways to detect brain damage early and identify which children are at higher risk.

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 ways to detect brain injury early in infants after heart surgery, helping doctors identify those who need extra monitoring or care.
What could go wrong
This is a small, early observational study with only 30 participants. It is not testing a treatment, so it may not directly change how children are cared for.

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 30 people

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

Started

May 2024

Expected to finish

Sep 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

Pediatric Clinic UMC Ljubljana

Ages

10 days to 1 year

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: * Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass). Exclusion Criteria: * Congenital heart disease not requiring extracorporeal circulation during surgery * Inoperable congenital heart defect * Hypoxic encephalopathy at birth requiring therapeutic hypothermia

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Conditions

The condition(s) this trial relates to.

Charcot-Marie-Tooth disease type 1F congenital heart disease Hypoxia, Brain perinatal asphyxia

As listed by the trial registrant

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

Congenital heart disease (CHD) Hypoxic encephalopathy

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

  • University Medical Center

    Ljubljana, 1000, Slovenia

More trials for these conditions

Other studies related to the condition(s) this trial covers.