BridgeMD
Tests treatment safety and results for Congenital Heart Disease
Official title Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
ClinicalTrials.gov ID: NCT06267430
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 7
You may be able to join if
- 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
You likely can't join if
- 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...
See the full 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...
- Sufficient comprehension of the Dutch language to understand the study information and to be able to fill out the Dutch questionnaires.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.