Epippain - Long-term Neurological Effects of Pain and Analgesia and Sedation Treatment in Neonates 
Head :
Carbajal Ricardo, INSERM UNITE 149. RECHERCHES EPIDEMIOLOGIQUES EN SANTE PERINATALE ET SANTE DES FEMMES
Last update : 09/05/2017 | Version : 2 | ID : 60122
| General | |
| Identification | |
| Detailed name | Long-term Neurological Effects of Pain and Analgesia and Sedation Treatment in Neonates |
| Sign or acronym | Epippain |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL: 01/07/2005 |
| General Aspects | |
| Medical area |
Pediatrics |
| Health determinants |
Iatrogenic |
| Keywords | painful procedures, analgesia, neurological development, neonatal critical period, Health events, neonatal intensive care |
| Scientific investigator(s) (Contact) | |
| Name of the director | Carbajal |
| Surname | Ricardo |
| Address | 75012 PARIS |
| ricardo.carbajal@trs.aphp.fr | |
| Unit | INSERM UNITE 149. RECHERCHES EPIDEMIOLOGIQUES EN SANTE PERINATALE ET SANTE DES FEMMES |
| Organization | INSERM |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | Fondation CNP, Fondation de France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ASSOCIATION URGENCES PEDIATRIQUES TROUSSEAU (HOPITAL ARMAND TROUSSEAU, PARIS) |
| 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. | Inclusion method: Retrospective Other bodies active in creating this cohort: CHU, CHG, INDEPENDENT PHYSICIANS |
| Database objective | |
| Main objective | To investigate the long-term neurological effects of pain as well as analgesia and sedation treatment administered to neonates |
| Inclusion criteria | Children who were hospitalised in intensive care during neonatal period |
| Population type | |
| Age |
Newborns (birth to 28 days) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Multicentric cohort in ILE-DE-FRANCE (13 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2005 |
| Date of last collection (YYYY or MM/YYYY) | 01/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 430 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview: Entry from a paper questionnaire (Manual input) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-EPIPPAIN |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-EPIPPAIN |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams Access permitted for social or parent relation evaluation for children hospitalised in intensive care during neonatal period Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
