Leuven Growing Into Deficit Follow-up Study - Full Text View

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:

MedlinePlus related topics: Heart Diseases

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 ]


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


Ages Eligible for Study:	84 Months to 89 Months (Child)
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

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:

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.


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:	January 7, 2016
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 Congenital Abnormalities Heart Defects, Congenital Disease Attributes	Pathologic Processes Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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