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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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 5, 2014
Last verified: February 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 5, 2014
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on March 02, 2015