PREMAG - Prevention of cerebral palsy by magnesium sulphate
Head :
Marret Stéphane, SERVICE DE PEDIATRIE NEONATALE ET REANIMATION. CHU & EA 4309 ENDOTHELIUM ET LESIONS CEREBRALES NEONATALES
Last update : 07/20/2015 | Version : 2 | ID : 60133
| General | |
| Identification | |
| Detailed name | Prevention of cerebral palsy by magnesium sulphate |
| Sign or acronym | PREMAG |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 12/02/1998 |
| General Aspects | |
| Medical area |
Neurology |
| Pathology (details) | Infant development |
| Keywords | Cerebral Palsy/prevention & control, Infant, Newborn, Premature, Magnesium, sulfate/therapeutic use, Meta-Analysis as Topic, Models, Animal, Neuroprotective Agents/therapeutic use, Randomized Controlled Trials as Topic, Female, Humans, Obstetric Labor, Premature/prevention & control, Pregnancy |
| Scientific investigator(s) (Contact) | |
| Name of the director | Marret |
| Surname | Stéphane |
| Address | 76031 ROUEN CEDEX |
| Stephane.marret@chu-rouen.fr | |
| Unit | SERVICE DE PEDIATRIE NEONATALE ET REANIMATION. CHU & EA 4309 ENDOTHELIUM ET LESIONS CEREBRALES NEONATALES |
| Organization | UNIVERSITE DE |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | PHRC, contrat FEDER 2011-2014 (bourse de recherche et financement du TEC) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de Rouen |
| 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 |
Yes |
| Details |
Performed at individual level |
| Database objective | |
| Main objective |
1. Determine the cognitive score at 8 years old.
2. Determine wether the child is schooled in general or specialized school. |
| Inclusion criteria | preterm children (prior to 33 weeks) |
| Population type | |
| Age |
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 | French multi-center cohort (13 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1998 |
| Date of last collection (YYYY or MM/YYYY) | 2002 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 688 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| 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 | Paper questionnaire filled up by the parents.Interviews paper questionnaire (manual entry)Clinical exams : hand written (manual entry) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | At 2 years old, and more recently around 11 years old by sending a questionnaire to the parents. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDc, MDPH |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-PREMAG |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Use of data non possible for academic teams.
Use of data non possible for indutrials. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
