EPIPAGE - Survival of very preterm infants ARCHIVE

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

Last update : 01/01/2018 | Version : 2 | ID : 3438

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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 Survival of very preterm infants
Sign or acronym EPIPAGE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL n° 911009 / CCTIRS 10.626
General Aspects
Medical area Neurology
Keywords morbidity, death rate, behaviour, cognitive capacities, school education
Scientific investigator(s) (Contact)
Name of the director Larroque
Surname Béatrice
Address HOPITAL ST VINCENT DE PAUL- 82 AVENUE DENFERT ROCHEREAU- BATIMENT LELONG-75014 PARIS
Phone +33 (0)1 40 87 57 07
Email béatrice.larroque@bjn.aphp.fr
Unit U953 - Unité de recherche épidémiologique en santé périnatale et santé des femmes et des enfants
Organization INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE -
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 INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE -
Collaborations
Funding
Funding status Mixed
Details PHRC National 2001, DGS, PHRC 8 ans, contrat MERCK DOLME/INSERM, Fondation de la recherche médicale, Fondation Wyeth
Governance of the database
Sponsor(s) or organisation(s) responsible INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - 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 care professionals
A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Maternity files and GP
Database objective
Main objective Study the evolution of severely preterm children born between 22 and 32 weeks of gestational age il 9 regions of France in 1997, and 2 comparison groups at 33-34 and 39-40 weeks.
Inclusion criteria Severely preterm children (birth or interruption 22-32 weeks of amenorrhea (SA) or weight between 0,5 and 1,499 Kg.
Control group: Group 1: 39-40 SA ; Groupe 2 : 33-34 SA in centers participating to the study.
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area 9 régions of France: Alsace, Franche-Comté, Languedoc - Roussillon, Lorraine, Midi-Pyrénées, Nord Pas-de-Calais, Haute Normandie, Pays de Loire and Paris and Petite couronne
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 01/1997
Date of last collection (YYYY or MM/YYYY) 01/2008
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 3219 sujets avec suivi accepté à la période néonatale: 2276 grands prématurés, 382 nés à 33- 34 semaines d'âge gestationel, 555 nés à 39-40 semaines d'âge gestationel
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Declarative data (detail) Paper self-questionnaire
Face to face interview
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method On inclusion: data from maternity files (pregnancy surveillance, identified pathologies, medical care used, childbirth, child health on birth...) or neonatology (pathology appearing while in the hospital, complications, medical care used, health of child when going out). sociodemographic data is gathered during an interview.Aftercare: At 2 years old, a medical exam (motricity-oriented) of the child is done by the GP. Parents are also interviewed. At 5 years old: weight, size, skull perimeter are measured and a neurologic exam and cgnitive tests are performed by a psychologist. An autoquestionnaire is sent to the parents at 9 months old, 1, 2, 3, 4, 5 and 8 years old. This questionnaire is adapted to the child's age andasks about his/her health and development, and gathers sociodemographic data.
Participant monitoring Yes
Details on monitoring of participants Aftercare of children until 8 years old
Links to administrative sources Yes
Linked administrative sources (detail) CédiDCA study in Departmental Homes for Disabled Persons (MDPH) was conducted for children with sequelae or if the parents did not answer.
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) Contact scientific investigator
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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