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
| 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 |
| 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 |
