Congenital Heart DiseaseQoLCHDNCT04812210
Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 30 Dec 2021
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Groupe 1 : Children with congenital heart disease aged 2 to 4 years Groupe 2 : Healthy children aged 2 to 4 years
Who may be able to join
- Children aged 2 to 4 years old.
- Group 2 : Chldren with CHD (as defined in the ACC-CHD classification).
Who cannot join
- Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, severe genetic disease).
- Surgical procedure during the last 6 months.
- Inability to understand the HRQoL questionnaire (parents) :non-french speaker, severe intellectual disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study
Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.
Read the detailed description
248 patients will be enrolled in this study (124 children in each group).
Patients from group 1 will be included during their annual medical check-up. HRQoL questionnaire, neurodevelopmental status scale and clinical status will be assessed during this site visit. No supplementary visit, directly related to the research, will be necessary. Three sites will participate to the study, members of he French national network for complex congenital heart diseases (M3C) .
Participants (healthy children) from group 2 will be included from kindergartens and schools. The prior agreement of the Ministry of National Education will be obtained before any procedure related to this study.
- Conditions
- Congenital Heart Disease
- Keywords
- health related quality of life, pediatrics, cardiology
- 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 |
|---|---|---|
| case: children with congenital heart disease aged 2 to 4 years. | case: children with congenital heart disease aged 2 to 4 years. | |
| control children recruited in kindergartens and schools aged 2 to 4 years | control children recruited in kindergartens and schools aged 2 to 4 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the total score of the proxy HRQoL questionnaire
Comparison of the total score of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and control children : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.
Measured: 1 day
Secondary outcomes (7)
Comparison of score by dimensions of the proxy HRQoL questionnaire
Comparison of score by dimensions of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and schoolchildren aged 2 to 4 years : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order o get score by dimensions of scale we must sum the items scores over the number of items answered. If more than 50% of the items in the scale are missing, the scale scores should not be computed.
Measured: 1 day
Comparison of score of the roxy HRQoL questionnaire
Comparison of score of the roxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the type of the CHD unsing the ACC-CHD classification : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 dimensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.
Measured: 1 day
Comparison of score of the proxy HRQoL questionnaire
Comparison of score of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the severity of the CHD unsing the BETHESDA classification : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be
Measured: 1 day
Comparison of score of the HRQoL questionnaire
Comparison of score of the HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the patient functional status unsing the Ross classification : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be
Measured: 1 day
Comparison of score of the proxy HRQoL questionnaire
Comparison of score of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the prognostic classification of the CHD unsing Davey B.T classification : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be
Measured: 1 day
Study of the association of the following variables related to the patient and to the CHD with the scores of the proxy HRQoL questionnaire
Study of the association of the following variables related to the patient and to the CHD with the scores of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) . Univariate end multivariate analysis will be performed. The variables are:
- sex of the patient,
- age at diagnosis of CHD (pre or post natal)
- cardiac clinical data
- neurodevelopmental status
Measured: 1 day
Evaluation of the psychometric properties of the proxy HRQoL questionnaire
Evaluation of the psychometric properties of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) . for children aged 2 to 4 years old : The Pediatric Quality of Life Inventory Version 4.0 (PedsQLTM 4.0) is a questionnaire widely used in pediatric clinical trials. This questionnaire was translated and linguistically validated in French, but no complete psychometric validation for French children aged 2 to 4 years has been performed yet. Reliability and validity are considered the main measurement properties of such instruments
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Montpellier - Inserm 1046 - PhyMeddExp, Saint Pierre Institute - Palavas les Flots, University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD-PhD, Study director, UH MONTPELLIERJohanna Calderon, Study chair, PhyMeddExpSophie Guillaumont, Principal investigator, Saint Pierre Institute - Palavas les FlotsJean-Benoit Thmabo, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812210
- Sponsor's protocol ID
- RECHMPL21_0083
- Acronym
- QoLCHD
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04812210
- Acronym / sponsor ID
- QoLCHD / RECHMPL21_0083
- Conditions
- Congenital Heart Disease
- Keywords
- health related quality of life, pediatrics, cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University of Montpellier - Inserm 1046 - PhyMeddExp, Saint Pierre Institute - Palavas les Flots, University Hospital, Bordeaux
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- 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.
Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.
Detailed description
248 patients will be enrolled in this study (124 children in each group).
Patients from group 1 will be included during their annual medical check-up. HRQoL questionnaire, neurodevelopmental status scale and clinical status will be assessed during this site visit. No supplementary visit, directly related to the research, will be necessary. Three sites will participate to the study, members of he French national network for complex congenital heart diseases (M3C) .
Participants (healthy children) from group 2 will be included from kindergartens and schools. The prior agreement of the Ministry of National Education will be obtained before any procedure related to this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case: children with congenital heart disease aged 2 to 4 years. | – | –case: children with congenital heart disease aged 2 to 4 years. |
| control children recruited in kindergartens and schools aged 2 to 4 years | – | –control children recruited in kindergartens and schools aged 2 to 4 years |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Groupe 1 : Children with congenital heart disease aged 2 to 4 years Groupe 2 : Healthy children aged 2 to 4 years
Key inclusion criteria (2 listed)
- Children aged 2 to 4 years old.
- Group 2 : Chldren with CHD (as defined in the ACC-CHD classification).
Key exclusion criteria (3 listed)
- Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, severe genetic disease).
- Surgical procedure during the last 6 months.
- Inability to understand the HRQoL questionnaire (parents) :non-french speaker, severe intellectual disability.
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
Comparison of the total score of the proxy HRQoL questionnaire
Time frame: 1 day
Comparison of the total score of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and control children : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.
7 secondary outcomes
Comparison of score by dimensions of the proxy HRQoL questionnaire
Time frame: 1 day
Comparison of score of the roxy HRQoL questionnaire
Time frame: 1 day
Comparison of score of the proxy HRQoL questionnaire
Time frame: 1 day
Comparison of score of the HRQoL questionnaire
Time frame: 1 day
Comparison of score of the proxy HRQoL questionnaire
Time frame: 1 day
Study of the association of the following variables related to the patient and to the CHD with the scores of the proxy HRQoL questionnaire
Time frame: 1 day
Evaluation of the psychometric properties of the proxy HRQoL questionnaire
Time frame: 1 day
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 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pascal AMEDRO, MD-PhD study director
UH MONTPELLIER
Johanna Calderon study chair
PhyMeddExp
Sophie Guillaumont principal investigator
Saint Pierre Institute - Palavas les Flots
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 Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 3 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 12 Apr 2022. 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 France. 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?
Comparison of the total score of the proxy HRQoL questionnaire (time frame: 1 day). 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 12 Apr 2022.