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