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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Heart Defects, Congenital; Child; Mental Processes; Critical Illness

Study type: Observational

Funder types: Other

Identifiers

NCT01632813

Leuven-GID

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 84 to 89 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

172 participants in 2 patient groups

CHD group

Description:

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

Description:

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.