EPIDEMIOLOGICAL STUDY ON SMALL GESTATIONAL AGES

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Thanks to the quality and relevance of the information you shared with us about your children over the years, we obtained an additional funding to allow us to consider other follow-up steps. We will therefore be happy to see you and your child, very soon, for their 10th birthday.

This new stage represents a major challenge for the study. Indeed, children have grown up, left early childhood and will be able, for the first time, if you agree, to be questioned directly about their daily lives, their aspirations and their relationships with others.

As usual, you and your child will be free to accept or refuse to participate in this new follow-up step.

Planned data collection

  • 1st step: a telephone interview, to ask you questions about your child’s health.
  • 2nd step: Home visit of a trained investigator. This visit is not mandatory. If you accept it, it will be the opportunity to have a direct first contact with your child, in your presence, of course. We will perform a physical examination of your child (measurements of weight, height, blood pressure) and propose him or her playful activities on tablet to evaluate different aspects of his or her health. Parents will also complete a small online questionnaire to assess their quality of life, among other things.

The whole team is at work to prepare for this new meeting and is looking forward to meeting you again! We are currently waiting for regulatory authorizations that will allow us to know when this step can begin. We will keep you informed very quickly of the start date of this new survey.

MODALITES PRATIQUES DE LA COLLECTE A 10 ANS

When will the investigation be carried out

The survey will take place between December 2021 and August 2022 close to the child’s 10th birthday.

2- How will it take place ?

This new 10-year follow-up step will take place in 3 stages:

  • 1st step: a phone interview, by an investigator-specifically trained, will allow to update  data regarding your household and collect information about your child's health, academic support, homework, education, your child's friends, etc. If you have twins, the interview will be longer to allow questions about each of your children.
  • 2nd step: a home visit of a specifically trained investigator: It will offer an opportunity to have a direct contact with your child, in your presence of course. After a short interview, a physical examination of your child (measurements of weight, height, blood pressure, breathing) will be carried out. We will evaluate different aspects of his reasoning, his language, his physical condition and motor skills. Parents will also complete an online questionnaire.
  • 3rd step: at the end of the visit the investigator will issue equipment and instructions allowwing you to collect your child's saliva, urine and hair. Regarding blood samples, you will be offered to contact a medical analysis laboratory, close to your place.  

You and your child may or may not participate in each of these steps. However, if you do not participate in the telephone interview, the home visit can not be offered to you. Likewise, if you do not participate in the home visit, we will not be able to drop you off the material for the biological component.

The whole team is hard at work preparing for this new meeting and can't wait to see you again!


This year, the telephone interviews for the home visit have been entrusted to the Ipsos institute.

You will be able to determine the date and time of the call yourself for the telephone survey as well as for the home visit.

If you have already given us your e-mail address, Ipsos will send you by e-mail a link to a platform which will allow you to make an appointment directly via the Internet. If we do not have your last contact details, please contact us by email (This email address is being protected from spambots. You need JavaScript enabled to view it.) or by phone at 01 56 01 71 85.

More information on data security and the rights of participants here

1-Are all families concerned by this survey?

Yes, but in two different formats:

  • Families residing in metropolitan France will be able to participate in all assessments (telephone interview, home visit, biological samples).
  • Families residing in Réunion, Guadeloupe, Martinique and Guyana will only be able to participate in the telephone interview, due to the logistical difficulties associated with moving investigators to their homes.

I live abroad, can I participate in this survey?

No, if you live abroad, you cannot participate in the survey.

Can I only do the phone interview?

Yes, you are free to accept only the phone interview.

 

How long does the telephone interview last?

It takes about 1 hour.

 

Will I be able to receive my child's and / or parents' cognitive test results?

No, there are no plans to disseminate these results individually. However, the overall results, for the entire cohort, will be sent to you at the end of this collection step.

I come home late from work, can the interviews be done at the end of the day or on Saturday?

Yes, the investigators will make themselves available. You can choose the date and time that suits you. 

If none of the parents can be present during the visit, can it still be organized?

Yes, only if the adult present knows the child very well and can answer the interviewer's questions. He/she must be close enough to the child allowing him/her to feel confident throughout the visit.

My child (ren) is (are) in shared custody, can we participate in the survey?

Yes, the questionnaires relate to the daily life of your child (ren). If you live together regularly, you can of course participate. Only one parent will be interviewed by phone.

Are the investigators who will come to my home health professionals (doctors, psychologists)?

No, the investigators who will visit you are not health professionals. However, they will be trained by doctors, psychologists and by the Epipage 2 coordination team in order to know how to deal with certain difficulties that your child (ren) may  present.

Will the investigators who come to my home be vaccinated against Covid 19?

Yes, all investigators should have received a complete vaccination schedule. They can, if you wish, show you the proof of vaccination upon arrival.

Will I be able to be present when the interviewer asks my child questions?

The entire home visit will obviously take place in your presence. You will also be able to find out in advance the questions that will be asked of your child.

My child may have some difficulty answering the questions on his/her own, will he/she be able to receive help from the interviewer?

Yes, according to your child’s wishes, the interviewer can help him write his answers on the tablet without influencing your child's responses.

What will the biological samples be used for?

The aim of biological samples is to see if certain conditions of birth, feeding method, environmental exposure induce variations already detectable at 10 years at the biological level. Blood sugar, triglyceride and cholesterol levels will be measured and the results will be sent to you.

 

How is the collection of biological samples carried out?

The biological collections (urine, saliva, hair) will be performed by your child, with your help, at your home. The blood sample should be taken in the morning at the laboratory (prior appointment is recommended), before your child has breakfast. The laboratory will also recover the biological samples taken at home. They will remain stored there until a transporter transfers them to the Epipage biobank where they will be centralized while awaiting analyzes.

 

If I do not participate in this survey, can I participate in the other Epipage 2 monitoring steps?

Yes, you are free to accept or refuse this new collection step. If you decline, it will not affect your participation in the Epipage 2 study. 

Will I be compensated for my trip to the laboratory?

Yes, a flat rate of 25 euros will be paid to you in compensation for your trip to the medical analysis laboratory.

 

If I do not participate in this survey, can I participate in the other Epipage 2 monitoring steps?

Yes, you are free to accept or refuse this new collection step. If you decline, it will not affect your participation in the Epipage 2 / Elfe study.