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

Development, Child Clinical Trial

— EPIPAGE2  

Official title:

EPIPAGE2 Cohort Study Follow up at Ten and a Half Years

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05243901
• Other study ID #: C20-68
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Development, Child
• Pre-Term
• Premature Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Relationship between parenting educational skills and children's quality of life	VSPA scale (Adolescent Experience and Perceived Health)	10 years and a half
Primary	Factors influencing children's puberty development	Tanner stage	10 years and a half
Primary	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