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Frequently asked questions

What are the Epipage 2 study's objectives ?

The objectives of this study are:

  • learn more about the outcome of very preterm infants born in France in 2011 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
  • discover more information about the causes of preterm birth and its consequences

How were children chosen to followed in this study ?

The study includes three groups of preterm children, after the families were informed:

  • extremely preterm infants (born before the end of the 6th month of pregnancy, between 22 and 26 completed weeks of gestation), born between March 28 and December 31, 2011 
  • very preterm infants (born before the end of the 7th month, between 27 and 31 completed weeks), born between March 28 and October 30, 2011
  • moderately preterm infants (born at the beginning of the 8th month, between 32 and 34 completed weeks), born between May 2 and June 5, 2011.
The recruitment period for children was adjusted according to gestational age at birth so that we would have an adequate number of each type of preterm birth, to be able to reach statistically valid conclusions.

Why are the children in Epipage 2 being followed up to the age of 12 years ?

Most children born preterm develop well during early childhood. Nonetheless, for different reasons linked to the immaturity of their brain at birth, or the complications they might have had at the beginning of their lives, or their neonatal hospitalization, they may later encounter behavior or learning problems. These difficulties may appear in primary school, or in middle school, when learning becomes more complex and the curriculum more demanding. They are still poorly known, although it is very important to be able to understand their causes and to prevent them. Follow-up will continue to the age of 12 years the age children reach middle school to respond to these questions.

Are there any other national or international studies of preterm birht ?

The first large-scale study of the outcome of very preterm babies in France was the Epipage 1 study of a cohort of children born in 1997. This study provided numerous results about the outcome of the children and about the value of some treatments or types of care. But management and care have changes substantially since 1997. We therefore need to know the situation for children who are born prematurely today to continue to improve their situation.
There are similar studies in other countries, which make it possible to compare both practices and results between countries. We see from the studies already published that practices can be very different from one country to another. The European EPICE project, which is taking place simultaneously, was designed to meet this objective, but for the moment, it is limited to a follow-up to the age of 2 years.
There are also studies limited to extremely preterm births, before 27 weeks, as the EPICURE 2 cohort in England, or the EXPRESS cohort in Sweden. Epipage 2 is also providing information about the children born at gestational ages up to 34 weeks.

Is it required to respond to the Epipage 2 survey ?

Your participation and your responses are essential to the study's quality, but you are entirely free to agree or refuse to your child's participation.

At each stage of the follow-up, you will be free to refuse to participate in the next stage.

What documents must I complete or sign to participate in the study ?

You participate in the study as long as you don't say that you do not want to participate. Thus, your oral agreement is sufficient for you to participate. Similarly, if you do not want to participate any more or at all, you just need to tell us, orally or in writing.

Who should fill out the questionnaires ?

For the 1-year and 2-years follow-ups, parents are supposed to fill out the questionnaires sent to the families. Parents can ask for help completing the form from a family member, their physician, their specialized child-care attendant at the PMI or their regional coordinator (by telephone).

For the 2-year follow-up, together with the questionnaire for the parents to complete, you will receive a shorter questionnaire that you should give to the doctor who sees the child, so that he/she can fill in medical information.

How should we fill out the questionnaires for the 3-year follow-up ?

You can either fill out the paper version that was sent to you by mail and send it back in the stamped, addressed envelope provided, or you can answer the questionnaire during phone with the coordinator who will call you if he notes that you didn't answered.

How do I get a login and a password to connect to the online questionnaire ?

The regional coordination sends you the login and password by e-mail or mail at each stage of the follow-up. If you have not received them or if you lost or misplaced them, you can contact your regional coordinator. To ensure the confidentiality of the data, only the coordinator of the region you live in can give you these identifiers.

What should I do if I cannot connect to the site or I cannot open the questionnaire ?

You need to know that once you've validated the questionnaire after you've filled it in, you no longer have access to it.

If you have problems connecting to the site and/or the questionnaire before you fill it out or while you are doing so, you can contact your regional coordination by telephone or by e-mail; they will try to resolve the problem.

Do I have to fill out several questionnaires if I have several children (twins or triplets) included in the study ?

Yes, you should fill out one questionnaire per child.

Nonetheless, the parts entitled "Your health and your living conditions", starting on page 21 of the 1-year follow-up questionnaire, and "Questions for the mother", starting on page 14 of the 2-years follow-up questionnaire, were to be filled out only once.

The shorter questionnaire for the doctor at the 2-year follow-up should also be filled out for each child.

How much time do I have to send back the questionnaire ?

The questionnaire was designed to be filled out at a specific age. The sooner the parents complete it after they receive it, the more precise the information communicated will be.

How do you keep the information you have collected confidential ?

The data collected will be analyzed anonymously, and participants' names will never appear in the results. We use secure procedures that have been validated by the CNIL (National Data Protection Authority).

Do the people participating in this survey have a right to access to the information about them and can they correct it if it's wrong ?

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.

Are the parents regularly informed about the status of the study ?

Yes, they receive a newsletter regularly. In addition, information is made available on the website: http://epipage2.inserm.fr

Can the Epipage 2 team answer questions about my child's health ?

The Epipage 2 team cannot in any case substitute for the medical team that cares for your child. But many pediatricians are involved in this study, and if you want to ask them questions or communicate with them, you can contact national coordination (regionals coordinations aren't contactable for the moment) which try to answer or direct you to the scientific supervisor in you region.

I filled out the 2-year follow-up questionnaire: what's next ?

Some children participate to complementary project  which require data collect at 3 years. These collecting are ongoing.

Concerning global cohort, the future stage will start during 2016, for the 5-year follow-up. One medical examination will be done. The conception is in process.

What should we do if we move ?

If you move, you should notify your national coordination. Your new contact information will be noted so that we can reach you for the next stages. If you move to another region, you will be followed in the new region, and that new regional coordination will send you the future questionnaires. If you move abroad for a limited period of time, we will continue to follow you and to send you the questionnaires. If you move permanently abroad, we can, if you want, continue to collect information about your child by sending you the study questionnaire at each phase. 
If you change your telephone number or e-mail address, you should also notify the national coordination.

Is a medical examination planned during the study ?

The first examination is planned for the year your child is 5. You will receive the details later. Other examinations should be organized during later stages of the follow-up.

How much time do I have to send back the faeces sample ?

There is no deadline to send back the faeces sample. However, this analyse is planned to be realised at the age of 3, so the faster you send it back, more accurate our results will be.

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