Leuven Growing Into Deficit Follow-up Study

Study Overview
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Brief Summary
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The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.

Official Title
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Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit

Conditions
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Heart Defects, Congenital, Critical Illness, Mental Processes, Child

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year). Exclusion Criteria: Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment IQ < 70 Lack of baseline neurocognitive measurements during first follow-up Date of birth before February 2005

Ages Eligible for Study
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Minimum Age: 84 Months
Maximum Age: 89 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHD group<br>Seven-year-old children with CHD who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year). | |
| Control group<br>Seven-year-old healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). These children have never undergone cardiac surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT) |  | one testpoint at age of 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT) |  | one testpoint at age of 7 years | 
| Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT) |  | one testpoint at age of 7 years | 
| Number of taps on computerized tapping tasks (ANT) |  | one testpoint at age of 7 years | 
| IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R) |  | one testpoint at age of 7 years | 
| Visual-Motor Integration total standard score (VMI) |  | one testpoint at age of 7 years | 
| Child Behavior CheckList T-scores for internalizing and externalizing problems |  | one testpoint at age of 7 years | 
| Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life |  | one testpoint at age of 7 years | 
| Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version) |  | one testpoint at age of 7 years | 
| Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school |  | one testpoint at age of 7 years | 
| Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up |  | one testpoint at age of 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurocognitive testing, critical illness, executive function, intelligence