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Leuven Growing Into Deficit Follow-up Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01632813
Acronym
Leuven-GID
Enrollment
172
Registered
2012-07-03
Start date
2012-07-31
Completion date
2014-09-30
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

neurocognitive testing, critical illness, executive function, intelligence

Brief summary

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.

Interventions

None listed

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
84 Months to 89 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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
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
Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of lifeone 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 schoolone testpoint at age of 7 years
Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-upone testpoint at age of 7 years
Child Behavior CheckList T-scores for internalizing and externalizing problemsone testpoint at age of 7 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026