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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
  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

Further study details as provided by Greet Van den Berghe, 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 ]

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 ]
  • 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 ]

Enrollment: 172
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: September 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

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Ages Eligible for Study:   84 Months to 89 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632813


Locations
Belgium
Dept Intensive Care Medicine
Leuven, Vlaams Brabant, Belgium, 3000
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
First Submitted: June 29, 2012
First Posted: July 3, 2012
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by Greet Van den Berghe, Katholieke Universiteit Leuven:
neurocognitive testing
critical illness
executive function
intelligence

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