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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632813
First Posted: July 3, 2012
Last Update Posted: January 8, 2016
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.
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
June 29, 2012
July 3, 2012
January 8, 2016
July 2012
September 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01632813 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Leuven Growing Into Deficit Follow-up Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Seven-year-old children with CHD and healthy seven-year-old control children
  • Heart Defects, Congenital
  • Critical Illness
  • Mental Processes
  • Child
Not Provided
  • 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.
Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
84 Months to 89 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01632813
Leuven-GID
No
Not Provided
Not Provided
Greet Van den Berghe, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Dieter Mesotten, MD PhD KU Leuven
Katholieke Universiteit Leuven
January 2016