Clinical trial NCT01632813: Leuven Growing Into Deficit Follow-up Study
Official title: Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Critical Illness
Mental Processes
Child
Keywords: neurocognitive testing
critical illness
executive function
intelligence
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 172
Sex: ALL
Minimum age (years): 84
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seven-year-old children with CHD and healthy seven-year-old control children

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.


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
* IQ \< 70
* Lack of baseline neurocognitive measurements during first follow-up
* Date of birth before February 2005

Primary outcomes:
measure: reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)
timeFrame: one testpoint at age of 7 years
Secondary outcomes:
measure: reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT)
timeFrame: one testpoint at age of 7 years
measure: Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)
timeFrame: one testpoint at age of 7 years
measure: Number of taps on computerized tapping tasks (ANT)
timeFrame: one testpoint at age of 7 years
measure: IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)
timeFrame: one testpoint at age of 7 years
measure: Visual-Motor Integration total standard score (VMI)
timeFrame: one testpoint at age of 7 years
measure: Child Behavior CheckList T-scores for internalizing and externalizing problems
timeFrame: one testpoint at age of 7 years
measure: Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life
timeFrame: one testpoint at age of 7 years
measure: Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)
timeFrame: one testpoint at age of 7 years
measure: Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school
timeFrame: one testpoint at age of 7 years
measure: Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up
timeFrame: one testpoint at age of 7 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Dept Intensive Care Medicine
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Dieter Mesotten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
citation: Sterken C, Lemiere J, Van den Berghe G, Mesotten D. Neurocognitive Development After Pediatric Heart Surgery. Pediatrics. 2016 Jun;137(6):e20154675. doi: 10.1542/peds.2015-4675.