Leuven Growing Into Deficit Follow-up Study (Leuven-GID)

January 7, 2016 updated by: Greet Van den Berghe, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Dept Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seven-year-old children with CHD and healthy seven-year-old control children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one testpoint at age of 7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
one testpoint at age of 7 years
Number of taps on computerized tapping tasks (ANT)
Time Frame: one testpoint at age of 7 years
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
one testpoint at age of 7 years
Visual-Motor Integration total standard score (VMI)
Time Frame: one testpoint at age of 7 years
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
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
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
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
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
one testpoint at age of 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Dieter Mesotten, MD PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (Estimate)

July 3, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leuven-GID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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