Congenital Heart DiseaseNCT02814539
Brain Function in Children With Congenital Heart Disease (CHD)
An observational study of Congenital Heart Disease, run by Bea Latal.
Trial summary
The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at… Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2019
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinic
Who may be able to join
- Congenital heart disease,
- Cardiopulmonary bypass surgery during first three months of life,
- No genetic syndrome,
- Gestational age > 37 weeks of gestation.
Who cannot join
- Heart surgery without cardiopulmonary bypass,
- Heart surgery not within first three months of life,
- Born <37 weeks of gestation,
- Any genetic syndrome detected.
About this study
Official title: Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions
The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.
- Conditions
- Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
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 |
|---|---|---|
| congenital heart disease | children with severe congenital heart disease who undergo open heart surgery during infancy | |
| healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Functions, assessed with D-KEFS
Measured: 2 years
Secondary outcomes (2)
slow wave activity on EEG
Measured: 2 years
MRI volumetry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bea Latal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Bea Latal, University Children's Hospital, Zurich
- Investigators
- Bea Latal, MD MPH, Principal investigator, University Childrens Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814539
- Sponsor's protocol ID
- BF_CHD_1
- Status last verified
- Sep 2019
- First submitted
- 23 Jun 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions
- ClinicalTrials.gov ID
- NCT02814539
- Acronym / sponsor ID
- BF_CHD_1
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bea LatalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Mar 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 27 Jun 2016 (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 purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congenital heart disease | – | –children with severe congenital heart disease who undergo open heart surgery during infancy |
| healthy controls | – | – |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Congenital heart disease,
- Cardiopulmonary bypass surgery during first three months of life,
- No genetic syndrome,
- Gestational age > 37 weeks of gestation.
Key exclusion criteria (4 listed)
- Heart surgery without cardiopulmonary bypass,
- Heart surgery not within first three months of life,
- Born <37 weeks of gestation,
- Any genetic syndrome detected.
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
Executive Functions, assessed with D-KEFS
Time frame: 2 years
2 secondary outcomes
slow wave activity on EEG
Time frame: 2 years
MRI volumetry
Time frame: 2 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 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Bea Latal, MD MPH principal investigator
University Childrens Hospital Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Bea Latal.
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 4 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Executive Functions, assessed with D-KEFS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.