ITMO public health
Last update : 07/07/2015 | Version : 3 | ID : 3582
| General | |
| Identification | |
| Detailed name | Physical and neurological becoming of highly premature children in the Aquitaine region |
| Sign or acronym | AQUIPAGE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Neurology Psychology and psychiatry |
| Health determinants |
Genetic Social and psychosocial factors |
| Keywords | Prematurity, natural history, neurosensory troubles, physical development anomalies, speech and language disorders, concentration disorders, emotional development anomalies., development, prognostic factors, mobility |
| Scientific investigator(s) (Contact) | |
| Name of the director | Joly-Pedespan |
| Surname | Laurence |
| Address | 146 rue Léo Saignat 33076 Bordeaux cedex |
| laurence.joly@chu-bordeaux.fr | |
| Unit | Unité Inserm : CIC-EC 07 |
| Organization | ISPED- Institut de Santé Publique d'Epidémiologie et de développement |
| Name of the director | Leroy |
| Surname | Valériane |
| Address | 146 rue Léo Saignat 33076 Bordeaux cedex |
| valeriane.leroy@isped.u-bordeaux2.fr | |
| Unit | Unité INSERM U 897 |
| Organization | ISPED- Institut de Santé Publique d'Epidémiologie et de développement |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC REGIONAL 2001 ET 2004 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre Hospitalier Universitaire de Bordeaux |
| 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. | Exhaustive recruitment of the births at 24-33 weeks of amenorrhea in the centers participating to the study. A collect of information concerning the proceeding of pregnancy and birth is realized from data from the patient file. |
| Database objective | |
| Main objective | Study the neurologic and physical becoming of highly premature children (birth between 24 and 33 weeks of amenorrhea) at long term (seven years), in the framework of a multi-center study in the Aquitaine region. Natural history, prognostic factors, occurrence of long term neurological sequelae, in particular minor and moderate, the least known. |
| Inclusion criteria | Living births, stillborn births between 24-33 weeks of amenorrhea, in the centers participating to the study. Exclusion criteria : congenital abnormalities. |
| 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 |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Aquitaine Limousin Poitou-Charentes |
| Detail of the geography area | Aquitaine |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2003 |
| Date of last collection (YYYY or MM/YYYY) | 01/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 633 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at inclusion and during the follow-up at 1, 4, 12, 18 and 24 months, then annually (neurologic check-up) Visual check-up (at 9 months and 2 years)Auditive check-up (at 1 and 3 years) Cognitive performance and psycho-emotional profile (at 1, 2, 4 and 7 years of adjusted age) |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Clinical examination at inclusion and during the follow-up at 1, 4, 12, 18 and 24 months, then annually (neurologic check-up) Visual check-up (at 9 months and 2 years)Auditive check-up (at 1 and 3 years) Cognitive performance and psycho-emotional profile (at 1, 2, 4 and 7 years of adjusted age) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/mortality |
| Procedures | |
| Data collection method | Standardized questionnaire of neonatal events and a neurologic check-up at 1, 4, 12, 18, 24 months; then annual neurologic examination until the age of 7. Neurosensory check-up at 9 months. Auditive check-up at 3 years. Cognitive performances and psycho-emotional profile at 12 months of adjusted age, 2, 4 and 7 years. An NRM imaging is scheduled at 18 months if severe or moderate sequelae are detected. |
| Quality procedure(s) used | Coherence request after computer data entry. Missing data checked with the original file. Doctors and subjects remainders for follow-up visits. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 7 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=Aquipage |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data utilization possible for academic teams. Additional access condition : analysis before inside the cohort |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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