EPICARD - Future development of children suffering from congenital heart diseases : a study in Ile de France

Head :
Khoshnood Babak, U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS
Goffinet François, U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS
Lelong Nathalie, U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS

Last update : 07/08/2015 | Version : 3 | ID : 271

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Future development of children suffering from congenital heart diseases : a study in Ile de France
Sign or acronym EPICARD
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL No. 903006, CPP 2013-A00234-14, ANSM 130214B-21
General Aspects
Medical area Pediatrics
Health determinants Genetic
Keywords Prenatal diagnosis, perinatal medicine, pediatrics, mortality, morbidity, development, KABC
Scientific investigator(s) (Contact)
Name of the director Khoshnood
Surname Babak
Address INSERM U953 Maternité de Port-Royal, 6ème étage 53 av. de l'Observatoire 75014 PARIS
Phone +33 (0)1 42 34 55 87
Email babak.khoshnood@inserm.fr
Unit U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS
Organization INSERM
Name of the director Goffinet
Surname François
Address INSERM U953 Maternité de Port-Royal, 6ème étage 53 av. de l'Observatoire 75014 PARIS
Phone +33 (0)1 42 34 55 87
Email francois.goffinet@cch.aphp.fr
Unit U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS
Organization INSERM -
Name of the director Lelong
Surname Nathalie
Address INSERM U953 Maternité de Port-Royal, 6ème étage 53 av. de l'Observatoire 75014 PARIS
Phone +33 (0)1 42 34 55 87
Email nathalie.lelong@inserm.fr
Unit U953 - RECHERCHE EPIDEMIOLOGIQUE EN SANTE PERINATALE ET SANTE DES FEMMES ET DES ENFANTS
Organization INSERM
Collaborations
Funding
Funding status Mixed
Details - PHRC national - Association AREMCAR - ITMO- Santé Publique - Abbvie (projet PULMOCARD)
Governance of the database
Sponsor(s) or organisation(s) responsible Institut national de la santé et de la recherche médicale (INSERM)
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Cases identification: - For cases diagnosed during pregnancy or at born: obstetrics and gynecology departments, multidisciplinary intensive care and departments, neonatology departments, pediatric mobile emergency and intensive care services, DFPE (health certificates) - For diagnosis after maternity ward: from pediatric cardiology departments, and the following centers: fetal echocardiology centers, neonatology and multidisciplinary intensive care departments, pediatric mobile emergency and intensive care service, DFPE - For children dead before all kind of heart disease diagnosis: pediatric mobile emergency and intensive care service, fetopathology and anatomopathology services and sudden death centers. The Arcs research cases in the centers participating with a different frequency, depending on expected cases.
Database objective
Main objective The objectives of the study are, from a cohort survey on a population of patients suffering from congenital heart diseases:
1) estimate the prevalence, the time of diagnosis, the medical and surgical care of congenital heart diseases infected newborns
2) Evaluate the mortality, the morbidity and future neural development of these children
3) Identify factors linked to short and long term prognosis, including the impact of the time of diagnosis, medical and surgical care of the children, as well as the role of the channels of health care, and socio-economic factors.
Inclusion criteria Children (or fetus) suffering from congenital heart diseases detected in prenatal screening, at birth or during the first year of life, born (or interrupted) between 2005 and 2008, from mothers residents in Paris or inner suburbs (92, 93, 94 departments)
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Population covered Sick population
Gender Male
Woman
Geography area Departmental
French regions covered by the database Île-de-France
Detail of the geography area Paris, innersuburbs (92, 93, 94)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 05/2005
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 2348
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Clinical data (detail) Medical registration
Declarative data (detail) Paper self-questionnaire
Face to face interview
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Others
Care consumption (detail) Hospitalization
Medicines consumption
Other (detail) Future neural development of the child
Procedures
Data collection method Data have been collected by the investigators from medical records of the centers participating to the study. Pediatricians filling the questionnaires (pediatric cardiology: diagnostic), at 1 year, and at 31/2 years and 8 years. Standardized neural development tests -K-ABC and NEPSY.
Participant monitoring Yes
Details on monitoring of participants Systematic review at 1 year of all the children and at 31/2 years for some of them (1165 children with a major congenital heart disease and a random sample (~15%) of children with a minor CIV/CIA) by a pediatrician. Follow up by mail for families who wasn't able to move.
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.hal.inserm.fr/EPICARD
Description List of publications in HAL
Link to the document http://tinyurl.com/Pubmed-EPICARD
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) Access to data with the accord fo the steering committee, priority to study participants
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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