Pre-TermEPIPAGE2NCT05243901
EPIPAGE 2 - 10-year Follow-up (RECONAI PROJECT)
An observational study of Pre-Term and Development, Child, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Epipage 2 (Epidemiological study on small gestational ages) is a prospective population-based national cohort implemented to better understand the short, mid and long term future of premature children. Read more about this study
- Who is it for?
- Ages 10 to 11 years
- Conditions the study is for
- Pre-Term, Development, Child
- How many people
- 2,383 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2022to 21 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children born before 35 weeks of amenorrhea still eligible for follow-up at 10 years of age
Who may be able to join
- Children initially included in the Epipage 2 study,
- Not lost to follow up (i.e. having participated in at least one of the Epipage 2 surveys since the age of 1 year),
- Neither parent has expressed a definitive refusal to participate in the follow-up study.
Who cannot join
- Refusal of the investigation by one of the two parents or holders of parental authority,
- Residence abroad
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM (National Institute of Health and Medical Research) - Université Paris Cité, INRAE, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé Team) Center for Epidemiology and Statistics
Paris, 74014
About this study
Official title: EPIPAGE2 Cohort Study Follow up at Ten and a Half Years
Epipage 2 (Epidemiological study on small gestational ages) is a prospective population-based national cohort implemented to better understand the short, mid and long term future of premature children.
This study was launched on 28 March 2011 by the researchers of the EPOPé team (Perinatal, Obstetric and Pediatric Epidemiology Research) of the Epidemiology and Biostatistics Research Centre (INSERM U1153), in collaboration with the Inserm 1027 Unit (Epidemiology and Analysis in Public Health: risks, chronic diseases and handicaps) and medical teams of public health and research in 25 French regions.
Read more
The study focuses on children born before 35 weeks of amenorrhea.
3 follow-up steps for children included in the cohort have already been completed at 1, 2 and 5 and a half years of age. Currently, nearly 4,000 children are still eligible for follow-up.
Since the children are 9 years old, the follow-up steps are shared with those set up in another birth cohort, the Elfe cohort (Étude Longitudinale Française depuis l'Enfance, (www.elfe-france.fr) ), as part of the RE-CO-NAI project.
The RE-CO-NAI project is a research platform on cohorts of children followed since birth in order to be able to study in a global and multidisciplinary way the major issues of the health, development and socialization of children.
This RE-CO-NAI project was funded by the EQUIPEX 2011 call for projects as part of future investments.
This protocol, which is part of the RECONAI project, concerns the fully shared follow-up phase, proposed in the 10th year for the children of the two cohorts.
Read the detailed description
The objectives of this new follow-up phase are to study:
- the relationships between prematurity, early growth and cardiometabolic disorders
- the relationship between parenting educational skills and children's quality of life
- the factors influencing children's puberty development
- the factors influencing the child's fitness and motor skills
Study design:
The 10 and a half year follow-up phase is a Category 2 Human Person Research (IHRP 2).
Study population The study population corresponds to all children who have participated in the Epipage 2 cohort since birth and whose parents did not wish to stop follow-up in the study. In total, nearly 4,000 children will be invited to participate in this new follow-up phase.
Methodology:
This follow-up phase will take place in 3 steps:
- A telephone interview with one of the parents living regularly with the child. Parents will be asked to answer several questions concerning their family situation, the school (homework, school support), the health, sleep and nutrition of the child, the general health and mental health of the parent interviewed, the employment situation, the living conditions and educational practices of the family.
- The home visit of the families of an investigator who will propose to the families several activities:
- An interview with the child about his relations with his siblings, his comrades, his involvement in domestic activities and an estimate of his quality of life;
- A physical examination measuring some of the child's health parameters and including tests of physical fitness and motor skills;
- A test of the child's cognitive abilities;
- A parent self-administered questionnaire including a parent's cognitive abilities test (self-administered);
- Biological samples from the child (blood, urine, saliva hair)
- Conditions
- Pre-Term, Development, Child
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationships between prematurity, early growth and cardiometabolic disorders
Different cardiometabolic parameters will be studied (90th percentile waist for age and sex, 90th percentile systolic or diastolic pressure for age and sex)
Measured: 10 years and a half
Relationship between parenting educational skills and children's quality of life
VSPA scale (Adolescent Experience and Perceived Health)
Measured: 10 years and a half
Factors influencing children's puberty development
Tanner stage
Measured: 10 years and a half
Factors influencing the child's fitness and motor skills
Children's Endurance and Motor Ability Test Results upper or equal to 75th percentile of distribution for sex
Measured: 10 years and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start17 Feb 2022
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,383 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243901
- Sponsor's protocol ID
- C20-68
- Acronym
- EPIPAGE2
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIPAGE2 Cohort Study Follow up at Ten and a Half Years
- ClinicalTrials.gov ID
- NCT05243901
- Acronym / sponsor ID
- EPIPAGE2 / C20-68
- Conditions
- Pre-Term, Development, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,383 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epipage 2 (Epidemiological study on small gestational ages) is a prospective population-based national cohort implemented to better understand the short, mid and long term future of premature children.
This study was launched on 28 March 2011 by the researchers of the EPOPé team (Perinatal, Obstetric and Pediatric Epidemiology Research) of the Epidemiology and Biostatistics Research Centre (INSERM U1153), in collaboration with the Inserm 1027 Unit (Epidemiology and Analysis in Public Health: risks, chronic diseases and handicaps) and medical teams of public health and research in 25 French regions.
The study focuses on children born before 35 weeks of amenorrhea.
3 follow-up steps for children included in the cohort have already been completed at 1, 2 and 5 and a half years of age. Currently, nearly 4,000 children are still eligible for follow-up.
Since the children are 9 years old, the follow-up steps are shared with those set up in another birth cohort, the Elfe cohort (Étude Longitudinale Française depuis l'Enfance, (www.elfe-france.fr) ), as part of the RE-CO-NAI project.
The RE-CO-NAI project is a research platform on cohorts of children followed since birth in order to be able to study in a global and multidisciplinary way the major issues of the health, development and socialization of children.
This RE-CO-NAI project was funded by the EQUIPEX 2011 call for projects as part of future investments.
This protocol, which is part of the RECONAI project, concerns the fully shared follow-up phase, proposed in the 10th year for the children of the two cohorts.
Detailed description
The objectives of this new follow-up phase are to study:
- the relationships between prematurity, early growth and cardiometabolic disorders
- the relationship between parenting educational skills and children's quality of life
- the factors influencing children's puberty development
- the factors influencing the child's fitness and motor skills
Study design:
The 10 and a half year follow-up phase is a Category 2 Human Person Research (IHRP 2).
Study population The study population corresponds to all children who have participated in the Epipage 2 cohort since birth and whose parents did not wish to stop follow-up in the study. In total, nearly 4,000 children will be invited to participate in this new follow-up phase.
Methodology:
This follow-up phase will take place in 3 steps:
- A telephone interview with one of the parents living regularly with the child. Parents will be asked to answer several questions concerning their family situation, the school (homework, school support), the health, sleep and nutrition of the child, the general health and mental health of the parent interviewed, the employment situation, the living conditions and educational practices of the family.
- The home visit of the families of an investigator who will propose to the families several activities:
- An interview with the child about his relations with his siblings, his comrades, his involvement in domestic activities and an estimate of his quality of life;
- A physical examination measuring some of the child's health parameters and including tests of physical fitness and motor skills;
- A test of the child's cognitive abilities;
- A parent self-administered questionnaire including a parent's cognitive abilities test (self-administered);
- Biological samples from the child (blood, urine, saliva hair)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born before 35 weeks of amenorrhea still eligible for follow-up at 10 years of age
Key inclusion criteria (3 listed)
- Children initially included in the Epipage 2 study,
- Not lost to follow up (i.e. having participated in at least one of the Epipage 2 surveys since the age of 1 year),
- Neither parent has expressed a definitive refusal to participate in the follow-up study.
Key exclusion criteria (2 listed)
- Refusal of the investigation by one of the two parents or holders of parental authority,
- Residence abroad
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationships between prematurity, early growth and cardiometabolic disorders
Time frame: 10 years and a half
Different cardiometabolic parameters will be studied (90th percentile waist for age and sex, 90th percentile systolic or diastolic pressure for age and sex)
Relationship between parenting educational skills and children's quality of life
Time frame: 10 years and a half
VSPA scale (Adolescent Experience and Perceived Health)
Factors influencing children's puberty development
Time frame: 10 years and a half
Tanner stage
Factors influencing the child's fitness and motor skills
Time frame: 10 years and a half
Children's Endurance and Motor Ability Test Results upper or equal to 75th percentile of distribution for sex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term and Development, Child, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships between prematurity, early growth and cardiometabolic disorders (time frame: 10 years and a half). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.