Heart Defects, CongenitalLeuven-GIDNCT01632813
Leuven Growing Into Deficit Follow-up Study
An observational study of Heart Defects, Congenital and Critical Illness, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 84 to 89 monthsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital, Critical Illness, Mental Processes
- How many people
- 172 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 84 to 89 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Seven-year-old children with CHD and healthy seven-year-old control children
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
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.
- Conditions
- Heart Defects, Congenital, Critical Illness, Mental Processes, Child
- Keywords
- neurocognitive testing, critical illness, executive function, intelligence
- Medical subject headings
- Heart Defects, Congenital, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)
Measured: one testpoint at age of 7 years
Secondary outcomes (10)
reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT)
Measured: one testpoint at age of 7 years
Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)
Measured: one testpoint at age of 7 years
Number of taps on computerized tapping tasks (ANT)
Measured: one testpoint at age of 7 years
IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)
Measured: one testpoint at age of 7 years
Visual-Motor Integration total standard score (VMI)
Measured: one testpoint at age of 7 years
Child Behavior CheckList T-scores for internalizing and externalizing problems
Measured: one testpoint at age of 7 years
Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life
Measured: one testpoint at age of 7 years
Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)
Measured: one testpoint at age of 7 years
Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school
Measured: one testpoint at age of 7 years
Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up
Measured: one testpoint at age of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greet Van den Berghe, KU Leuven
- Investigators
- Dieter Mesotten, MD PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632813
- Sponsor's protocol ID
- Leuven-GID
- Acronym
- Leuven-GID
- Status last verified
- Jan 2016
- First submitted
- 29 Jun 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19176240Sterken C, Lemiere J, Van den Berghe G, Mesotten D. Neurocognitive Development After Pediatric Heart Surgery. Pediatrics. 2016 Jun;137(6):e20154675. doi: 10.1542/peds.2015-4675.
PubMed 27245833
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
- ClinicalTrials.gov ID
- NCT01632813
- Acronym / sponsor ID
- Leuven-GID / Leuven-GID
- Conditions
- Heart Defects, Congenital, Critical Illness, Mental Processes, Child
- Keywords
- neurocognitive testing, critical illness, executive function, intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 84 to 89 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Seven-year-old children with CHD and healthy seven-year-old control children
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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
Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)
Time frame: one testpoint at age of 7 years
Number of taps on computerized tapping tasks (ANT)
Time frame: one testpoint at age of 7 years
IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)
Time frame: one testpoint at age of 7 years
Visual-Motor Integration total standard score (VMI)
Time frame: one testpoint at age of 7 years
Child Behavior CheckList T-scores for internalizing and externalizing problems
Time frame: one testpoint at age of 7 years
Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life
Time frame: one testpoint at age of 7 years
Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)
Time frame: one testpoint at age of 7 years
Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school
Time frame: one testpoint at age of 7 years
Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up
Time frame: one testpoint at age of 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 19176240Vlasselaers 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.
- Derived from this study: PubMed 27245833Sterken C, Lemiere J, Van den Berghe G, Mesotten D. Neurocognitive Development After Pediatric Heart Surgery. Pediatrics. 2016 Jun;137(6):e20154675. doi: 10.1542/peds.2015-4675.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Mesotten, MD PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital and Critical Illness, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.