Leuven Growing Into Deficit Follow-up Study

Critical Illness Clinical Trial

— Leuven-GID  

Official title:

Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632813
• Other study ID #: Leuven-GID
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: January 7, 2016
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 84 Months to 89 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Child
• Congenital Abnormalities
• Critical Illness
• Heart Defects, Congenital
• Mental Processes

Locations

Country	Name	City	State
Belgium	Dept Intensive Care Medicine	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)		one testpoint at age of 7 years	No
Secondary	reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT)		one testpoint at age of 7 years	No
Secondary	Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)		one testpoint at age of 7 years	No
Secondary	Number of taps on computerized tapping tasks (ANT)		one testpoint at age of 7 years	No
Secondary	IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)		one testpoint at age of 7 years	No
Secondary	Visual-Motor Integration total standard score (VMI)		one testpoint at age of 7 years	No
Secondary	Child Behavior CheckList T-scores for internalizing and externalizing problems		one testpoint at age of 7 years	No
Secondary	Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life		one testpoint at age of 7 years	No
Secondary	Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)		one testpoint at age of 7 years	No
Secondary	Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school		one testpoint at age of 7 years	No
Secondary	Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up		one testpoint at age of 7 years	No