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EPIPAGE 2

epimomsObjectifs

Background

This national study (EPIPAGE 2) of preterm birth in France began 2011, conducted by the research team Obstetric, Perinatal and Pediatric Epidemiology (EPOPé), in collaboration with numerous regional teams of obstetricians, midwives, pediatricians, and epidemiologists.

Objectives

  • To learn more about the outcomes of very preterm and late preterm babies
  • To improve knowledge about the causes and consequences of preterm births
  • To assess the effects of the organization of care and of medical practices on the health and development of preterm babies
  • To improve our knowledge of the experiences of families and of the decision-making processes at childbirth and in the intensive care units
  • To define specific healthcare and other services required during childhood.

Study methodology

Population

EPIPAGE 2 is a cohort study of very preterm (22+0 to 31+6 weeks) and moderately preterm (32+0–34+6 weeks) babies, born in 21 regions of metropolitan France and 4 overseas districts (Martinique, Réunion, Guadeloupe, and French Guyana). The children were included at birth in 2011 (28 March–31 December 2011) and will be followed through the age of 12 years. Recruitment took place at birth in all maternity units in the participating regions.

Data collection

At birth, information about pregnancy, delivery, and immediate care of the child was collected in the maternity ward, from the medical files. At the end of the hospitalization in the neonatology department, a complete description of the care provided and medical complications was collected from the medical file. Information was also collected by an interview with each family and a self-administered questionnaire completed by the mothers.

Follow-up of the children

The first stage of data collection, at a corrected age of 1 year, took place in 2012-2013. Parents were asked to complete a questionnaire about the child’s health and medical care during the first year, as well as the family’s health and living conditions.
The data collection at a corrected age of 2 years took place in 2013-2014 and included a questionnaire for the parents and another for the doctor, to assess as well as possible the children’s first stages of psychomotor development.
For the subsequent stages, assessments including medical examinations and psychological tests will be organized in regional centers at the ages of 5, 8, and 12 years.
Regional groups, supervised by the national coordination team, are responsible for the cohort follow-up.

Complementary projects

Projects complementary to EPIPAGE 2 are being conducted among some subgroups of children in some regions and/or some centers. The objective of these studies is to relate aspects of the children’s outcomes to: neonatal cerebral abnormalities on MRI (Epirmex), quantity and type of milk received during the first weeks of life (Epinutri), and intestinal flora (Epiflore). Others will study placental histology (Chorist), or possible genetic modifications observed in samples of cord and maternal blood (Biopag). Still others are looking at mother-child interactions (Olimpe) or the role of health-care professionals and parental involvement in decisions and practices related to palliative care in extremely preterm births (Ethics).

Projects associated with EPIPAGE 2

National dimension

EPIPAGE 2 is a partner of the ELFE study (http://www.ELFE-france.fr), which included more than 18 000 children born in 2011 and is following them up at the same rhythm as we follow up the EPIPAGE 2 cohort. This will make it possible to compare these two populations (children born preterm versus born at term) for some aspects of development, health care, and environment.
EPIPAGE 2 is also associated with the EPIPPAIN 2 study, which is examining painful procedures and practices among children hospitalized in the NICU.

European dimension

EPIPAGE 2 is also associated with the EPICE European project (www.epiceproject.eu), coordinated by Jennifer Zeitlin. Together they offer the opportunity to study the diversity of practices for the management of preterm children in Europe, an essential domain for understanding differences in results between countries and identifying effective therapeutic and preventive strategies.

Funding

  • The Very Large Research Infrastructure program, through support from the French Institute of Public Health Research/Institute of Public Health and its partners: the French Health Ministry, the National Institute of Health and Medical Research (INSERM), the National Institute of Cancer, and the National Solidarity Fund for Autonomy (CNSA).
  • The National Research Agency through the French EQUIPEX program for investments in the future 2011
  • Fondation PREMUP

Partners

  • Collège National des Gynécologues et Obstétriciens Français (CNGOF, French College of Gynecologists and Obstetricians)
  • Société Française de Médecine Périnatale (SFMP, French Society for Perinatal Medicine)
  • Société Française de Néonatologie (SFN, French Society of Neonatology)
  • SOS Préma

To learn more

  • Ancel PY, Goffinet F; EPIPAGE 2 Writing Group.
    EPIPAGE 2: a preterm birth cohort in France in 2011.
    BMC Pediatr. 2014 Apr 9;14:97.