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Completed

NCT Number: NCT01632813

Leuven Growing Into Deficit Follow-up Study

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Child Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Critical Illness Disease Attributes Heart Diseases Mental Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

84 month–89 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept Intensive Care Medicine

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)

    Time frame: one testpoint at age of 7 years

  3. Number of taps on computerized tapping tasks (ANT)

    Time frame: one testpoint at age of 7 years

  4. IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)

    Time frame: one testpoint at age of 7 years

  5. Visual-Motor Integration total standard score (VMI)

    Time frame: one testpoint at age of 7 years

  6. Child Behavior CheckList T-scores for internalizing and externalizing problems

    Time frame: one testpoint at age of 7 years

  7. Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life

    Time frame: one testpoint at age of 7 years

  8. Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)

    Time frame: one testpoint at age of 7 years

  9. Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school

    Time frame: one testpoint at age of 7 years

  10. Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up

    Time frame: one testpoint at age of 7 years

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: Leuven-GID

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2012
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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