EDEN - Study on the pre and early postnatal determinants of child health and development

Head :
Heude Barbara, U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS
Charles Marie-Aline, U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS

Last update : 07/08/2015 | Version : 3 | ID : 60037

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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 Study on the pre and early postnatal determinants of child health and development
Sign or acronym EDEN
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL n°902267 (2002), CPP 0270 (12/12/2002)
General Aspects
Medical area Endocrinology and metabolism
Study of allergies
Health determinants Addictions
Climate
Genetic
Geography
Nutrition
Occupation
Pollution
Social and psychosocial factors
Keywords Health outcome, male reproductive system, metabolism, motor and cognitive development, growth, adiposity, infections, blood pressure, environment
Scientific investigator(s) (Contact)
Name of the director Heude
Surname Barbara
Phone +33 (0)1 45 59 51 85
Email barbara.heude@inserm.fr
Unit U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS
Organization Inserm
Name of the director Charles
Surname Marie-Aline
Phone +33 (0)1 45 59 51 05
Email marie-aline.charles@inserm.fr
Unit U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS
Organization Inserm
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Mixed
Details Fondation pour la recherche médicale, Inserm, Ministère de la recherche, Université Paris Sud, ANR, AFSSET, DGS, InVS, Nestlé, INPES, DGS, ALFEDIAM, Société SAVANTE, MGEN, IReSP, Commission européenne...
Governance of the database
Sponsor(s) or organisation(s) responsible Institut National de la Santé et de la Recherche Médicale
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 by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Prospective follow-up until 8 years
Database objective
Main objective Examine relationships between on the one hand, exposition and pregnancy related health factors, in utero fetal development, newborn health and child health during first months of life, and on the other hand, later child health and development
Inclusion criteria Adult women (≥18years) presenting before 22 gestational age at first prenatal visit, able to speak and read french
Population type
Age Newborns (birth to 28 days)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Population covered General population
Gender Woman
Geography area Local
French regions covered by the database Alsace Champagne-Ardenne Lorraine
Aquitaine Limousin Poitou-Charentes
Detail of the geography area French multicentric cohort; 2 centres: Nancy and Poitiers
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 01/2003
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 2002 femmes/women, 1898 nouveau-nés/newborns
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data Clinical examination during pregnancy and at birth for the mother and at birth, 1, 3 and 5 years for the offspring. Collected information concerning mother: medical records, post partum period, ultrasound data; and concerning the offspring: growth, adiposity, bone development, cognitive development, blood pressure, heart rate, dental examination, spirometry (5 years)
Declarative data (detail) Face to face interview
Details of collected declarative data Clinical examination during pregnancy and at birth for the mother and at birth, 1, 3 and 5 years for the offspring. Collected information concerning mother: medical records, post partum period, ultrasound data; and concerning the offspring: growth, adiposity, bone development, cognitive development, blood pressure, heart rate, dental examination, spirometry (5 years)
Paraclinical data (detail) Ultrasound
Biological data (detail) ciological samples: maternal and paternal blood; placenta; maternal hair and urine; colostrum in breastfeeding mothers; cord blood; child meconium and hair at birth; child blood and urine at 5 years
Presence of a biobank Yes
Contents of biobank Serum
Plasma
Cord blood
Fluids (saliva, urine, amniotic fluid, …)
DNA
Details of biobank content urine, colostrum, hair, placenta pieces
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method auto-questionnaire: manual entering from paper questionnaireclinical examinations: direct enteringbiological data: manual entering
Participant monitoring Yes
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.hal.inserm.fr/EDEN
Description List of publications in HAL
Link to the document http://tinyurl.com/Pubmed-EDEN
Description List of publications in Pubmed
Access
Dedicated website https://eden.vjf.inserm.fr/
Terms of data access (charter for data provision, format of data, availability delay) Possible use of data by academic teams. Possible use of data by industry
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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