ITMO public health
Last update : 11/26/2019 | Version : 2 | ID : 7578
| General | |
| Identification | |
| Detailed name | Effective Perinatal Intensive Care in Europe |
| Sign or acronym | EPICE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1585577 |
| General Aspects | |
| Medical area |
Gynecology/ obstetrics Pediatrics |
| Health determinants |
Genetic Healthcare system and access to health care services Social and psychosocial factors |
| Keywords | very preterm infants, evidence based médicine, neonatal intensive care. neurodevelopmental outcomes. follow-up at 2-5 years of age. european consortium. |
| Scientific investigator(s) (Contact) | |
| Name of the director | Zeitlin |
| Surname | Jennifer |
| Address | 53 avenue de l'Observatoire 75014 PARIS |
| Phone | +33 (0)1 42 34 55 77 |
| jennifer.zeitlin@inserm.fr | |
| Unit | U1153 Recherche épidémiologique en santé périnatale et santé des femmes et des enfantsÉquipe/activité : Épidémiologie clinique et organisation des soins |
| Organization | Institut National de la Santé et de la Recherche Médicale |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | SHIPS (Screening to Improve Health in Very Preterm Infants in Europe). RECAP Preterm (Research on European Children and Adults born Preterm). |
| Funding | |
| Funding status |
Public |
| Details | Epice is a Collaborative Project funded under the European Commission’s 7th Framework Programme (259882) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale - INSERM |
| 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. |
Very preterm infants born before 32 weeks of gestation.
Followed-up at 2 and 5 years of age. |
| Database objective | |
| Main objective |
To improve the survival and long-term health of very preterm infants by ensuring that medical knowledge is translated into effective perinatal care.
To assess care provided in the first five years of life and neurodevelopmental outcomes at 2 and 5 years of age. |
| Inclusion criteria | very preterm infants born before 32 week of gestation |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | 19 regions in 11 European countries (Belgium, Denmark, Estonia, France, Germany, Italy, Netherlands, Poland, Portugal, UK, Sweden) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2011 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 10000 pregnancy. 6800 survival to discharge. 5000 follow-up at 2 or 5 years of age. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Characteristics of pregnancy, Birth and infant's health status. Neurodevelopmental status at 5 years of age. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Characteristics of pregnancy, infant and child's health status and development. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Quality of life/perceived health (detail) | Neurodevelopment, health and wellbeing. |
| Procedures | |
| Data collection method | Quantitative and qualitative methods to collect information on the use of evidence-based practices at the patient, unit and regional levels. Parent report questionnaires. Medical assessment. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | Follow-up at 2 and 5 years of age. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=epice+AND+cohort+AND+%28Zeitlin+J+[Author]+OR+Bonet+M+[Author]%29 |
| Description | EPICE publications. |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the website |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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