EPIPAGE 2 - Epidemiological study on low gestational age infants 2

Head :
Ancel Pierre-Yves, U953 - Unité de recherche épidémiologique en santé périnatale et santé des femmes et des enfants

Last update : 07/08/2015 | Version : 2 | ID : 3411

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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 Epidemiological study on low gestational age infants 2
Sign or acronym EPIPAGE 2
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL n°911009 / CCTIRS n°10.626 / CPP SC-2873
General Aspects
Medical area Gynecology/ obstetrics
Pediatrics
Health determinants Genetic
Keywords Perinatality, neonatal mortality and morbidity (respiratory, neurological, infectious, metabolic), neural development (motor, sensory, cognitive), growth), handicaps
Scientific investigator(s) (Contact)
Name of the director Ancel
Surname Pierre-Yves
Address HOPITAL ST VINCENT DE PAUL- 82 AVENUE DENFERT ROCHEREAU- BATIMENT LELONG-75014 PARIS
Phone +33 (0)1 56 01 83 63
Email pierre-yves.ancel@inserm.fr
Unit U953 - Unité de recherche épidémiologique en santé périnatale et santé des femmes et des enfants
Organization INSERM
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Mixed
Details Ce projet a été financé grâce au soutien de:1) l’Institut de Recherche en Santé Publique / Institut Thématique Santé Publique, et des partenaires financeurs suivants : Ministère de la santé et des sports, Ministère délégué à la recherche, Institut National de la Santé et de la Recherche Médicale, Institut National du Cancer et Caisse Nationale de solidarité pour l’Autonomie.2) la fondation PREMUP3) Programme EQUIPEX des Investissements d'avenir dans le cadre de la plateforme RE-CO-NAI
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 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. End of inclusions: 01/12/2011
Database objective
Main objective More than 10 years are passed since the beginning of the EPIPAGE study. The evolutions occurred since justify the creation of a new cohort.

The main objectives of EPIPAGE 2 are:

1) Study the becoming of extremely premature children and their families
2) The evaluation of care organization effects and medical practice on premature children’s health and development
3) Research of causes and consequences of prematurity
4) Study the path of the different families and the decisions process at the moment of birth and intensive care
5) The needs analysis of medical and educational care

One of the originalities of the study is to have permitted the creation of complementary and multidisciplinary projects, in order to reply and deepen to question difficult to handle on the children of the cohort. These projects, based on the same structure of EPIPAGE 2, needs additional investigations and an own funding.
A total of 8 studies have been developed in the field of brain imaging, bio-markers, nutrition, mother-child interaction and ethics:

- ETHIQUE (decision process leading to survival or death of children born between 22 and 26 weeks of amenorrhea)
- EPIFLORE (study of the introduction of the intestinal microbiota)
- EPIRMEX (Study of the executive functions and of the language development, depending on anomalies detected through NRM)
- BIOPAG (Identification of the early bio-markers of pathologies from an umbilical cord sample (DNA, RNA)
- OLIMPE (Study of the existing links between the quality of early mother-child interactions and the neural and developmental becoming)
- CHORHIST (Research of chorioamniontides through anatomo-pathological analysis of placenta)
- EPINUTRI (Study of the associations of the intake of polyunsaturated fatty acids, iron intake and neurological becoming of extremely premature children)
- EPIPAIN 2 (treatment of painful movements in neonatal intensive care.

RE-CO-NAI platform
EPIPAGE 2 is one of the two cohorts constituting the RE-CO-NAI platform, together with the ELFE cohort.
The general objective of this platform is to create an infrastructure offering the measures required for collecting, highly secured storage and distribution of data concerning the pregnancy, the birth and the child.
The research platform consist of cohorts of infants followed since birth will allow to study, in a global and multidisciplinary way, the stakes on health, development and socialization of children.
It will in addition provide substantial visibility in the world of academic research (French and international), but also with regards to bodies, associations, and industries that have interests in children. As such, it will allow for an optimized valorization of the data collected and will facilitate the dissemination of data.
Inclusion criteria EPIPAGE 2 is a population based perspective cohort. All the children born in 25 regions of France, extremely premature (22-26 weeks of amenorrhea) on 8 months, highly premature (27-31 weeks of amenorrhea) on 6 months and moderately premature (32-34 weeks of amenorrhea) on 1 month. A control group of full-born children will be constituted from Elfe study. Children of families having expressed a refusal will not be included. In this case, the information from the health certificate of the 8th day could be used to characterize the population concerned.
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 General population
Gender Male
Woman
Geography area National
Detail of the geography area 21 regions of metropolitan France and 4 overseas regions (Martinique, Guadeloupe, Guyana, Réunion)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 04/2011
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals - 8398 prématurés/premature births and Induced therapeutic abortions/avortements - 7595 enfants/children
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Details of collected clinical data Clinical examination at inclusion and during the follow-up (birth, 2 years, 5years, 8 years, 11-12 years). Information collected through the clinical examination: motor, sensory, cognitive development, height and weight growth, respiratory pathologies
Declarative data (detail) Paper self-questionnaire
Face to face interview
Details of collected declarative data Clinical examination at inclusion and during the follow-up (birth, 2 years, 5years, 8 years, 11-12 years). Information collected through the clinical examination: motor, sensory, cognitive development, height and weight growth, respiratory pathologies
Biological data (detail) Biological data from coming from the medical record. For a sub-sample of children (n=150), umbilical cord blood has been taken
Presence of a biobank Yes
Contents of biobank Whole blood
Cord blood
Fluids (saliva, urine, amniotic fluid, …)
Tissues
Others
Details of biobank content Maternal blood, umbilical cord blood, stools of the newborn. The constitution of the biological collections that will allow a number of early exposures, as well as markers of health condition, is one of the specific objectives of the two studies of the RE-CO-NAI platform.
Health parameters studied Health event/morbidity
Health event/mortality
Quality of life/health perception
Procedures
Data collection method At birth (inclusion), clinical data are collected from the medical record and the medical teams, as well as information from the mother about pregnancy, delivery, intensive care (self-questionnaire and interview with the mother). During the follow-up, data are collected at 2, 5, 8 and 12 years. -A clinical and psychological check-up will be realized at 5, 8 and 12 years (motor, sensory, cognitive development, height and weight growth, respiratory pathologies) - Data concerning child's health, his development, his schooling, his quality of life, possible handicaps, consequences on the family are collected through a self-questionnaire submitted to the mother at 1, 2, 5, 8 and 12 years.
Quality procedure(s) used Coherence request during and after computer data entry. Missing data checked back to the original file. Subjects an doctors remainders for follow-up visits. Internal quality audit report. Patients receive information about the use of their data.
Participant monitoring Yes
Details on monitoring of participants Children will be followed until 12 years old.
Links to administrative sources Yes
Linked administrative sources (detail) SNIIRAM (file under preparation)
Promotion and access
Promotion
Link to the document http://www.hal.inserm.fr/EPIPAGE
Description List of publications in HAL
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=epipage+OR+25541510[uid]+OR+19932945[uid]
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) Data utilization possible for academic teams. Access to every interested research team after an evaluation of the project by the scientific council
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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