Clinical trial NCT05243901: EPIPAGE 2 - 10-year Follow-up (RECONAI PROJECT)
Official title: EPIPAGE2 Cohort Study Follow up at Ten and a Half Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Term
Development, Child
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2022-02-17
Enrollment: 2383
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born before 35 weeks of amenorrhea still eligible for follow-up at 10 years of age

Brief 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.

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:

1. 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.
2. 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);
3. Biological samples from the child (blood, urine, saliva hair)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Refusal of the investigation by one of the two parents or holders of parental authority,
* Residence abroad

Primary outcomes:
measure: Relationships between prematurity, early growth and cardiometabolic disorders
timeFrame: 10 years and a half
measure: Relationship between parenting educational skills and children's quality of life
timeFrame: 10 years and a half
measure: Factors influencing children's puberty development
timeFrame: 10 years and a half
measure: Factors influencing the child's fitness and motor skills
timeFrame: 10 years and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: 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
Study officials:
References: