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

KU Leuven1 site in 1 country172 target enrollmentJuly 2012

ConditionsHeart Defects, Congenital Critical Illness Mental Processes Child

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Defects, Congenital
Sponsor: KU Leuven
Enrollment: 172
Locations: 1
Primary Endpoint: reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Greet Van den Berghe

Head of Dept Intensive Care Medicine

KU Leuven

Eligibility Criteria

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
•Lack of baseline neurocognitive measurements during first follow-up
•Date of birth before February 2005

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
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)
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)