
- What is Epipage 2 ?
- What are its objectives ?
- How does it work ?
- Who is participating ?
- Where are we now ?
- What laws and regulations apply to this study ?
What is Epipage 2 ?
Epipage 2 (epidemiological study on small gestational ages) is a nationwide study to improve our knowledge of the outcome of preterm children in France.
This study was launched on March 28, 2011, by researchers of Inserm Unit 1153 (Obstetrical, Perinatal and Pediatric Epidemiolgoy Research Team), in collaboration with Perinatal epidemiology and childhood disabilities, Adolescent health research team, part of Inserm Unit 1027 Center for epidemiology and analyses in Public Health, and medical public health and research groups from 25 French regions.This study includes three groups of preterm children, all were born before 35 weeks:- extremely preterm infants (born before the end of the 6th month of pregnancy, between 22 and 26 completed weeks of gestation)
- very preterm infants (born before the end of the 7th month, between 27 and 31 completed weeks)
- moderately preterm infants (born at the beginning of the 8th month, between 32 and 34 completed weeks).
These children are being studied from their birth up to the age of 12 years.Epipage 2 follows the first Epipage study (Epipage 1), in which the same research team studied all of very preterm babies born in 9 regions of France in 1997. Epipage 1 produced new knowledge of the causes of very preterm birth, its consequences, and the benefits of some treatments. The situation has changed since 1997. There are more preterm children, their survival has improved, and practices in obstetrics and in neonatology have developed. It is therefore essential to know what is happening to the preterm children born today, after their first weeks of life.
The studies of these children will provide new and original information about their long-term outcome and about the effects on it of advances made in recent years. These results will provide valuable assistance to medical teams who care for and follow these children and provide better information to families.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).
What are its objectives ?
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.
How does it work ?
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.1st 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.2nd 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:Ages Methods of follow-up 1 year Questionnaire Parents 2 years Questionnaires Parents and general practitioner 5,5 years Assessment 1
QuestionnairePhysician, psychologist
Parents8 years Assessment 2
QuestionnairePhysician, psychologist
Parents12 years Assessment 3
QuestionnairePhysician, psychologist
ParentsThe principal results will be sent to the families regularly throughout the follow-up.
Who is participating ?
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.
Poitou-Charentes
Do not participate in this study
Languedoc-Roussillon
Number of level 3 maternity units: 3
Number of level 2 maternity units: 7
Number of level 1 maternity units: 10
Number of initial inclusions: 306Alsace
Number of level 3 maternity units: 2
Number of level 2 maternity units: 6
Number of level 1 maternity units: 8
Number of initial inclusions: 234Aquitaine
Number of level 3 maternity units: 3
Number of level 2 maternity units: 6
Number of level 1 maternity units: 19
Number of initial inclusions: 288Auvergne
Number of level 3 maternity units: 1
Number of level 2 maternity units: 6
Number of level 1 maternity units: 3
Number of initial inclusions: 107Basse-Normandie
Number of level 3 maternity units: 2
Number of level 2 maternity units: 8
Number of level 1 maternity units: 5
Number of initial inclusions: 169Burgundy
Number of level 3 maternity units: 1
Number of level 2 maternity units: 6
Number of level 1 maternity units: 6
Number of initial inclusions: 182Rhône-Alpes
Number of level 3 maternity units: 5
Number of level 2 maternity units: 20
Number of level 1 maternity units: 31
Number of initial inclusions: 806Centre
Number of level 3 maternity units: 2
Number of level 2 maternity units: 8
Number of level 1 maternity units: 12
Number of initial inclusions: 199Guadeloupe
Number of level 3 maternity units: 2
Number of level 2 maternity units: 0
Number of level 1 maternity units: 3
Number of initial inclusions: 106Limousin
Number of level 3 maternity units: 1
Number of level 2 maternity units: 3
Number of level 1 maternity units: 4
Number of initial inclusions: 72Lorraine
Number of level 3 maternity units: 1
Number of level 2 maternity units: 8
Number of level 1 maternity units: 12
Number of initial inclusions: 210Martinique
Number of level 3 maternity units: 1
Number of level 2 maternity units: 1
Number of level 1 maternity units: 2
Number of initial inclusions: 68Midi-Pyrénées
Number of level 3 maternity units: 1
Number of level 2 maternity units: 10
Number of level 1 maternity units: 16
Number of initial inclusions: 299Nord-Pas-de-Calais
Number of level 3 maternity units: 5
Number of level 2 maternity units: 13
Number of level 1 maternity units: 17
Number of initial inclusions: 583Champagne-Ardenne
Number of level 3 maternity units: 2
Number of level 2 maternity units: 7
Number of level 1 maternity units: 5
Number of initial inclusions: 132French Guyana
Number of level 3 maternity units: 1
Number of level 2 maternity units: 2
Number of level 1 maternity units: 1
Number of initial inclusions: 115PACA-Corsica
Number of level 3 maternity units: 5
Number of level 2 maternity units: 19
Number of level 1 maternity units: 25
Number of initial inclusions: 543Reunion
Number of level 3 maternity units: 2
Number of level 2 maternity units: 4
Number of level 1 maternity units: 1
Number of initial inclusions: 201Bretagne
Number of level 3 maternity units: 4
Number of level 2 maternity units: 11
Number of level 1 maternity units: 10
Number of initial inclusions: 318Picardie
Number of level 3 maternity units: 1
Number of level 2 maternity units: 10
Number of level 1 maternity units: 8
Number of initial inclusions: 163Haute-Normandie
Number of level 3 maternity units: 2
Number of level 2 maternity units: 5
Number of level 1 maternity units: 7
Number of initial inclusions: 198The Loire River region
Number of level 3 maternity units: 3
Number of level 2 maternity units: 10
Number of level 1 maternity units: 11
Number of initial inclusions: 422Franche Comté
Number of level 3 maternity units: 1
Number of level 2 maternity units: 7
Number of level 1 maternity units: 2
Number of initial inclusions: 129Ile-de-France
Number of level 3 maternity units: 15
Number of level 2 maternity units: 44
Number of level 1 maternity units: 40
Number of initial inclusions: 1954Where are we now ?
What laws and regulations apply to this study ?
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).