EPIPAGE 2 - 10-year Follow-up (RECONAI PROJECT)

NCT05243901 | Completed

• 1 other identifier: C20-68
• Study Type: observational
• Target: 2,383
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Term; Development, Child

Outcome Measures

Primary Outcomes (4)

• 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)

  10 years and a half

• Relationship between parenting educational skills and children's quality of life

  VSPA scale (Adolescent Experience and Perceived Health)

  10 years and a half

• Factors influencing children's puberty development

  Tanner stage

  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

  10 years and a half

Eligibility Criteria

• Age: 10 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children born before 35 weeks of amenorrhea still eligible for follow-up at 10 years of age

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

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, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 17, 2022
• Study Start: February 17, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)