This project was made possible through the support of the Institute for Public Health Research/Public Health Topics Institute and its funding partners (the Ministry of Health and Sports, the Ministry of Research, the National Institute for Health and Medical Research (Institut national de la santé et de la recherche médicale, Inserm), the National Cancer Institute (Institut national du cancer), and the National Fund of Solidarity for Autonomy (Caisse National de solidarité pour l'Autonomie)) and of the EQUIPEX program of investments in the future (request for proposals coordinated by the National Research Agency).

This study will provide answers to numerous questions about very preterm birth and allow us to:

• Learn more about the outcome of very preterm infants and their families
• Assess the effects of the organization of care and of medical practices on the health and development of preterm babies
• Define the specific needs for care during childhood
• Understand the paths families travel
• Improve knowledge about the causes of preterm birth
• Discover more information about its consequences:
  
  • By studying the cerebral abnormalities that some children may have and their prognostic value for neurological development and for cognitive function disorders
  • By analyzing the effect of nutrition and of abnormalities in the development of intestinal flora on the child's health and development
  • By looking for biomarkers of complications related to preterm birth
• Understand and analyze the ethical questions raised by care for extremely preterm children at their birth and in intensive care departments.

The Epipage 2 study is taking place in several stages:

• A phase for setting up the cohort,
• A first stage of follow-up when the children are one year old,
• A second stage of follow-up at the age of 2 years,
• Follow-up stages will be set up when children will reach the age of 5, 8 and 12.

Initial phase, cohort set-up, from March 28 to December 31, 2011

This study included all births (livebirths, stillbirths, and terminations of pregnancy) occurring from 22 to the end of 34 weeks of gestation during this period, after the families were informed.

We collected data about the mother (pregnancy, delivery, and experience of this birth) and the child (health status at birth, course of hospitalization) from the medical records.

1^st stage: follow-up at the age of 1 year, beginning in April 2012

This stage included all the children discharged from the neonatology department whose parents, informed there about the follow-up stages, did not express their refusal.
When the child reached the age of 1 year, their families were contacted by e-mail, mail or telephone.
Data were collected about the children's health during this first year and about their family situation.

2^nd stage: follow-up at the age of 2 years, beginning in April 2013

This stage includes the same families as the 1-year follow-up (whether or not they had been contacted or had responded), except those who subsequently refused further participation. Regional coordinators contact them by e-mail, mail, or telephone. The data collected concerne child development; more specific medical data are also collected from the physician who follows the child.

Subsequent stages of follow-up

We will contact the families again when the children reach the ages of 5, 8, and 12 years.

The table below summarizes the follow-up envisioned throughout the Epipage 2 study:

The principal results will be sent to the families regularly throughout the follow-up.

Epipage 2 took place in 21 of the 22 regions of metropolitan France and in 4 overseas regions. It began on March 28, 2011, in 7 French regions (Alsace, Burgundy, French Guyane, Languedoc-Roussillon, Limousin, Midi-Pyrénées, and Rhône-Alpes) and on May 2, 2011, in the other regions (Aquitaine, Auvergne, Basse-Normandie, Bretagne, Centre, Champagne-Ardenne, Franche-Comté, Haute-Normandie, Ile-de-France, Lorraine, Nord-Pas-de-Calais, PACA-Corsica, the Loire River region, Picardie, Martinique, Reunion, and Guadeloupe). All the maternity units and neonatology departments of these regions participated in this study, for a total of slightly more than 540 maternity units and 280 neonatology departments.

There are different types of maternity wards:

• Level 1 maternity units have an obstetrics department and handle normal pregnancies as well as some frequent, non-serious situations. The presence of a pediatrician enables examination of the newborn.
• Level 2A maternity units have an obstetrics unit and a neonatology unit that can care for newborns who might have moderately serious conditions.
• Level 2B units also have an obstetrics unit and a neonatology unit; in addition, they have intensive care cribs to provide more intense monitoring and care for more severe conditions.
• Level 3 maternity wards have an obstetrics unit, a neonatology unit, and a neonatal intensive care unit to provide management for high-risk pregnancies and newborns in severe distress.

During the inclusion period, 8417 preterm births (livebirths, stillbirths, and terminations of pregnancy) took place in the maternity units. 93% of the families (representing 7804 births) agreed to participate in the study.
The map below shows the participating maternity units and the number of births included by region.

Click on the region to see the information for it.

As of today, most of the children included in the Epipage 2 study have reached their 9th birthday. A survey of the schools they attend is underway. The next stage of follow-up is envisioned at the age of 10 years.

The Epipage 2 study is sponsored by the National Institute for Health and Medical Research (Institut national de la santé et de la recherche médicale) (INSERM). The Ile-de-France Patient Protection Committee 3 approved the study and its data processing plans on March 18, 2011, as did the National Data Protection Authority (CNIL) on March 24, 2011 (both before the study began). These approvals demonstrate that the study as planned complies with the rights of children and families.

Epipage 2 is what is called a "routine care" study. That is, it involves no experimentation or interventions at all, but simply studies the results of following the standard accepted procedures. Information must be supplied, but written consent is not required, although patients or families can choose to opt out. Accordingly, all families received a memo explaining the study's purpose and procedures. Families were included in the study if they did not expressly refuse to participate. 

Participation in the study is voluntary. It is possible to withdraw from the study at any moment, without any effect at all on the child's treatment or the family's relationship with the medical staff. The quality of the study and its results nonetheless depends on participation at all stages, including the follow-up.

The data collected will be analysed anonymously, and participants' names will never appear in the results. In compliance with the law related to information technology and liberties, people included in the study have a right to access and correct the computerized data concerning them and a right to oppose the transmission of these data. These rights can be exercised by contacting the study's regional coordinator or regional supervisor (for the moment, regional coordinator aren't in fonction, but for any question, you can contact the national coordinator).