AVCNN - French Cohort on Neonatal Cerebral Artery Infarction

Head :
Chabrier Stéphane, INSERM, CIE3, F-42055 SAINT-ETIENNE

Last update : 07/24/2015 | Version : 3 | ID : 60090

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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 French Cohort on Neonatal Cerebral Artery Infarction
Sign or acronym AVCNN
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Accord CNIL : 24/03/2004
General Aspects
Medical area Physical medicine and rehabilitation
Health determinants Genetic
Keywords History, miscarriage, primiparity, first gestation, twin pregnancy, premature rupture of membranes, caesarean section, foetal distress, monitoring, medical care, reeducation and rehabilitation, information
Scientific investigator(s) (Contact)
Name of the director Chabrier
Surname Stéphane
Address 42055 SAINT-ETIENNE
Phone + 33 (0)4 77 82 87 29
Email stephane.chabrier@chu-st-etienne.fr
Unit INSERM, CIE3, F-42055 SAINT-ETIENNE
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Mixed
Details Public: Inserm, Ministère de la Santé et des Solidarités, CHU de SAINT-ETIENNE, Privé: Fondation Motrice, Association des paralysés de France, Fondation Garches
Governance of the database
Sponsor(s) or organisation(s) responsible CHU de Saint-Etienne
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
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 Inclusion cut-off date: 01/10/2006 Other bodies active in creating this cohort: CHU, CHG
Database objective
Main objective General objective: to determine the clinical and biological obstetric-neonatal profile for full-term newborns presenting symptomatic arterial ischaemic stroke. Secondary objectives: - to determine the mechanisms of infarction from obstetric history, laboratory tests and imaging. - To monitor motor, cognitive and epileptic outcomes in children as well as their autonomy and quality of life until primary school.
Inclusion criteria All participating newborns hospitalised by neonatal and paediatric neurology services. Full-term newborns presenting perinatal arterial ischaemic stroke were included i.e.: - presenting neurological symptoms (convulsions, malaise, hypotonia, impaired vigilance, asymmetric tone or motor skills) in the first 28 days of life; - Brain imaging (by CT or MRI scan) showing appearance of ischaemic-like lesions in an arterial location; - parents or those with parental authority who gave their consent after explanation of the protocol aims and modalities by the local investigating party and who received an explanatory document. Exclusion criteria: - premature births; - asymptomatic neonates i.e. systematic discovery of an immediate pre- or post-natal image abnormality or children presenting with aposteriori cerebral palsy; - children with diffuse hypoxic-ischaemic lesions i.e more than three affected arterial territories or venous infarction; - where clinical and biological follow-up is impossible; - parental refusal to be included in the study or refusal to sign molecular biology consent form.
Population type
Age Newborns (birth to 28 days)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Multicentric cohort throughout France (39 centres) Geographical area covered: 39 neonatal and paediatric neurology services throughout the metropolitan territory: ANNEMASSE, AULNAY SOUS BOIS, AUXERRE, AVIGNON, BAYONNE, BEAUVAIS, BESANÇON, BONDY, BREST, CAHORS, CARCASSONE, CHALON SUR SAÔNE, CLAMART, CLERMONT-FERRAND, CREIL, CRÉTEIL, EVRY, FONTAINEBLEAU, GRENOBLE, LE KREMLIN-BICÊTRE, LILLE, LIMOGES, LYON, MARSEILLES, MONTPELLIER, NANTES, ORSAY), PARIS (ROBERT DEBRÉ, SAINT-VINCENT DE PAUL) PÉRIGUEUX, ROUEN, SAINT-DENIS, SAINT-ETIENNE, TOULOUSE, TOURS, VANNES, VERSAILLES, VILLEFRANCHE SUR SÂONE AND VILLENEUVE SAINT-GEORGES.
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 11/2003
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 100
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Face to face interview
Paraclinical data (detail) Imaging
Biological data (detail) Thrombophilia research for mother and child
Presence of a biobank No
Health parameters studied Quality of life/health perception
Procedures
Data collection method Self-administered questionnaire: from a paper questionnaire Interview: from a paper questionnaire Clinical examination: manual input and double data entry Biological analysis: manual input and double data entry
Participant monitoring Yes
Details on monitoring of participants Clinical examination at birth, at one year, two years and seven years old. Self-administered questionnaire at the age of three and half and seven years old. Neuropsychological and speech therapy evaluation at seven years old.
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://tinyurl.com/Hal-Publis-AVCnn
Description List of publications in HAL
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=AVCNN+OR+19541515[uid]
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) Data may be used by academic teams To be decided if data may be used by industrial teams.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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