Leuven Growing Into Deficit Follow-up Study (Leuven-GID)
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ClinicalTrials.gov Identifier: NCT01632813 |
Recruitment Status
:
Completed
First Posted
: July 3, 2012
Last Update Posted
: January 8, 2016
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Condition or disease |
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Heart Defects, Congenital Critical Illness Mental Processes Child |
Study Type : | Observational |
Actual Enrollment : | 172 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Group/Cohort |
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CHD group
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).
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Control group
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.
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- reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT) [ Time Frame: 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) [ Time Frame: one testpoint at age of 7 years ]
- Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT) [ Time Frame: one testpoint at age of 7 years ]
- Number of taps on computerized tapping tasks (ANT) [ Time Frame: one testpoint at age of 7 years ]
- IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R) [ Time Frame: one testpoint at age of 7 years ]
- Visual-Motor Integration total standard score (VMI) [ Time Frame: one testpoint at age of 7 years ]
- Child Behavior CheckList T-scores for internalizing and externalizing problems [ Time Frame: one testpoint at age of 7 years ]
- Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life [ Time Frame: one testpoint at age of 7 years ]
- Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version) [ Time Frame: one testpoint at age of 7 years ]
- Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school [ Time Frame: one testpoint at age of 7 years ]
- Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up [ Time Frame: one testpoint at age of 7 years ]

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Ages Eligible for Study: | 84 Months to 89 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632813
Belgium | |
Dept Intensive Care Medicine | |
Leuven, Vlaams Brabant, Belgium, 3000 |
Principal Investigator: | Dieter Mesotten, MD PhD | KU Leuven |
Publications:
Responsible Party: | Greet Van den Berghe, Head of Dept Intensive Care Medicine, Katholieke Universiteit Leuven |
ClinicalTrials.gov Identifier: | NCT01632813 History of Changes |
Other Study ID Numbers: |
Leuven-GID |
First Posted: | July 3, 2012 Key Record Dates |
Last Update Posted: | January 8, 2016 |
Last Verified: | January 2016 |
Keywords provided by Greet Van den Berghe, Katholieke Universiteit Leuven:
neurocognitive testing critical illness executive function intelligence |
Additional relevant MeSH terms:
Critical Illness Congenital Abnormalities Heart Defects, Congenital Disease Attributes |
Pathologic Processes Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |