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Baby heart surgery study aims to protect tiny brains

NCT ID NCT04992793

Knowledge-focused Sponsor: University of Leicester 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at 38 infants under 1 year old with congenital heart disease who needed heart surgery. The goal was to understand why some babies get brain injuries during surgery and to gather data for developing better monitoring tools. Researchers used MRI scans and blood samples to find risk factors, and will follow up when the children turn 2.

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 research could lead to better monitoring tools to prevent brain injury during heart surgery in babies.
What could go wrong
This is a small, completed observational study (38 participants) focused on data collection, not a treatment trial. The findings may not apply to all infants or lead directly to new tools.

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

38 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2024

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

Babies (\<1 year) undergoing surgery for congenital cardiac disease

Ages

Up to 12 months

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: * Parents/Carers should be willing to provide written informed consent for their child to participate in the study * Patients should be under 1 year of age. * Patients with congenital cardiac conditions of any type and severity can be included * Patients undergo cardiac surgery (any strategy). Exclusion Criteria: * Unable (in the investigator's opinion) to comply with the study requirements. * Known pre-existing brain conditions, and genetic or inflammatory syndromes known to affect brain development.

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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.

Congenital heart disease

Contacts and locations

Locations

  • University Hospitals of Leicester NHS Trust

    Leicester, United Kingdom

More trials for these conditions

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