Leuven Growing Into Deficit Follow-up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Heart Defects, Congenital Critical Illness Mental Processes Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

84 Months

Maximum Eligible Age

89 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes