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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632813
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Greet Van den Berghe, KU Leuven

Tracking Information
First Submitted Date June 29, 2012
First Posted Date July 3, 2012
Last Update Posted Date January 8, 2016
Study Start Date July 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2012)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2012)
  • 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 ]
  • Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT) [ Time Frame: one testpoint at age of 7 years ]
  • Number of taps on computerized tapping tasks (ANT) [ Time Frame: 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 ]
  • Visual-Motor Integration total standard score (VMI) [ Time Frame: 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 ]
  • Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life [ Time Frame: 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 ]
  • Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Leuven Growing Into Deficit Follow-up Study
Official Title Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Seven-year-old children with CHD and healthy seven-year-old control children
Condition
  • Heart Defects, Congenital
  • Critical Illness
  • Mental Processes
  • Child
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 7, 2016)
172
Original Estimated Enrollment
 (submitted: June 29, 2012)
182
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 84 Months to 89 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01632813
Other Study ID Numbers Leuven-GID
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Greet Van den Berghe, KU Leuven
Study Sponsor KU Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Dieter Mesotten, MD PhD KU Leuven
PRS Account KU Leuven
Verification Date January 2016