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

This study is currently recruiting participants.
Verified February 2013 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01632813
First received: June 29, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Heart Defects, Congenital
Critical Illness
Mental Processes
Child

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT) [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Number of taps on computerized tapping tasks (ANT) [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R) [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Visual-Motor Integration total standard score (VMI) [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Child Behavior CheckList T-scores for internalizing and externalizing problems [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version) [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]
  • Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up [ Time Frame: one testpoint at age of 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 182
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   84 Months to 89 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632813

Contacts
Contact: Caroline Sterken, MSc 003216340988 caroline.sterken@med.kuleuven.be

Locations
Belgium
Dept Intensive Care Medicine Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Caroline Sterken, MSc     003216340988     caroline.sterken@med.kuleuven.be    
Sub-Investigator: Jurgen Lemiere, MSc,PhD            
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Dieter Mesotten, MD PhD KU Leuven
  More Information

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
Study First Received: June 29, 2012
Last Updated: February 14, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
neurocognitive testing
critical illness
executive function
intelligence

Additional relevant MeSH terms:
Congenital Abnormalities
Critical Illness
Heart Defects, Congenital
Disease Attributes
 Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 23, 2013