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Brain training for tiny hearts: can a Game-Like program sharpen young minds after heart surgery?

NCT ID NCT06267430

Disease control Sponsor: Erasmus Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a personalized training program called 'Kleuter Extra' can improve executive functioning—skills like attention, self-control, and planning—in preschoolers aged 4 to 6 who have severe congenital heart disease. Many children with this condition face thinking and attention challenges that can affect their development. The study compares the training to usual care and also looks at how the parent-child relationship may influence progress.

What this could mean

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

Active substance
a personalized behavioral training program called 'Kleuter Extra'
What this could lead to
If effective, this program could improve attention, self-control, and problem-solving skills in young children with severe heart disease, boosting their developmental outcomes.
What could go wrong
This is a relatively small, early-stage trial. The training may not work for all children, and benefits might not last long-term. Parent-child dynamics could also influence results.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

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

Started

May 2024

Expected to finish

Oct 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.

Ages

4 to 7 years

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.

In order to be eligible to participate in this study, a child must meet all of the following criteria: * Aged 4.0 - 6.0 years upon inclusion OR aged 6.0-7.0 years who are still in kindergarten (group 1 \& 2 of the Dutch school system) * Required CHD surgery in the first six months of life (with or without ECMO) or a cyanotic CHD that required surgery in the first 12 months of life * IQ estimated \> 55 (no moderate to severe intellectual disability) * Diminished EF based on a below average score on any of the subtests of the 'KleuterExtra' test battery (≤ 21 percentile) at t = 0 * Sufficient comprehension of the Dutch language by the child to be able to participate in the EF test battery and the EF training program. In order to be eligible to participate in this study, the parent(s) must meet the following criteria: * Sufficient comprehension of the Dutch language to understand the study information and to be able to fill out the Dutch questionnaires. Exclusion Criteria: * Children receiving targeted EF support at school upon inclusion. * Children with severe brain damage (estimated IQ \< 55) * Genetic syndromes known to directly affect cognitive performance (e.g. Down syndrome) * Children with severe psychiatric disorders upon inclusion that require treatment first, such as a posttraumatic stress disorder, separation anxiety disorder, or reactive attachment disorder.

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Conditions

The condition(s) this trial relates to.

attention deficit-hyperactivity disorder Cognition Disorders congenital heart disease

As listed by the trial registrant

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

Attention disorder Congenital heart disease Executive dysfunction

Contacts and locations

Locations

  • Erasmus Medical Center Sophia Children&#39;s Hospital

    Rotterdam, Rotterdam, 3015CN, Netherlands

  • University Medical Center - Beatrix children&#39;s hospital Groningen

    Groningen, Provincie Groningen, 9713GZ, Netherlands

  • University Medical Center - Wilhelmina children's hospital Utrecht

    Utrecht, Utrecht, 3584EA, Netherlands

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