Leuven Growing Into Deficit Follow-up Study

Completed

• Conditions: Child; Heart Defects, Congenital; Mental Processes; Critical Illness

• Registration Number: NCT01632813
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-06-29
• Study Start: 2012-07
• Study First Posted: 2012-07-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)	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
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
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

Trial Locations

Locations (1)

Dept Intensive Care Medicine; 🇧🇪 Leuven, Vlaams Brabant, Belgium