EPIPAGE2 Cohort Study Follow up at Ten and a Half Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,383
- Locations
- 1
- Primary Endpoint
- Factors influencing the child's fitness and motor skills
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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)
Factors influencing children's puberty development
Time Frame: 10 years and a half
Tanner stage
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)
Secondary Outcomes
No secondary outcomes reported