NCT06267430 Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
| NCT ID | NCT06267430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 141 participants in total. It began in 2024-05-01 with a primary completion date of 2025-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome.
Eligibility Criteria
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 (≤ 25 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.
Contact & Investigator
André Rietman
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06267430 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 7 Years, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06267430 currently recruiting?
Yes, NCT06267430 is actively recruiting participants. Contact the research team at e.oppelaar@erasmusmc.nl for enrollment information.
Where is the NCT06267430 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Rotterdam, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT06267430 clinical trial?
NCT06267430 is sponsored by Erasmus Medical Center. The principal investigator is André Rietman at Erasmus Medical Center. The trial plans to enroll 141 participants.