THE EPICE COHORT
The EPICE cohort
The cohort includes all stillbirths and live births between 22 and 31 weeks of gestation born in all the maternity units of the 19 regions that participated in the EPICE project. All regions started inclusions between March and July 2011 and the inclusion period lasted for one year, except in France where they lasted 6 months. Over 10 000 births, of which almost 8000 are live births, were included in the study.
Objectives and methods
Investigators abstracted data from medical records in obstetrical and neonatal units using a pretested standardised questionnaire with common definitions. Gestational age was defined as the best obstetric assessment based on information on last menstrual period and antenatal ultrasounds, which are part of routine obstetrical care in all regions. Inclusions were cross-checked against delivery ward registers or another external data source. Infants were followed up until discharge home from hospital or into long-term care or death.
At 2 years of age, questionnaires were sent to parents to obtain information on longer term health outcomes based on parental assessments. The aim was to assess motor and cognitive development at 2 years of corrected age in order to carry out standardised comparisons of the outcomes for very preterm infants across Europe in terms of their health, growth and development and to compare with other published work. We also collected data on healthcare and follow-up services.
Ethics approval was obtained in each region from regional and/or hospital ethics committees, as required by national legislation. The European study was also approved by the French Advisory Committee on Use of Health Data in Medical Research (CCTIRS) and the French National Commission for Data Protection and Liberties (CNIL).
The number of inclusions in the cohort at birth and at 2 years of age is presented in the table below.
|Very preterm live births and stillbirths in 2011/2012||Newborns discharged home from the neonatal unit||Children participating in the 2 year follow-up|
|Denmark: Eastern Region||441||286||180|
|Estonia: whole country||179||141||138|
|Italy : Marche||134||98||81|
|UK: East Midlands||742||510||253|
|UK: Yorkshire and Humber||921||646||290|