EPIPAGE2 Cohort Study Follow up at Five and a Half Years (EPIPAGE2)

April 10, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years

Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).

These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.

At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3404

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Centre Hopsitalier d'Agen
      • Albi, France, 82000
        • CAMSP Albi
      • Amiens, France, 80000
        • CHU Amiens
      • Angers, France, 49933
        • CHU d'Angers
      • Arras, France, 62022
        • CH d'Arras
      • Auch, France, 32000
        • CAMSP Auch
      • Bayonne, France, 64100
        • Centre Hospitalier Côte Basque
      • Beauvais, France, 40319
        • CH Beauvais
      • Besançon, France, 25030
        • Chu Jean Minjoz
      • Bordeaux, France, 33000
        • Centre Hospitalier de Bordeaux
      • Bourg-en-Bresse, France, 01012
        • CH Bourg en Bresse
      • Brest, France, 29609
        • CHU de Brest
      • Brioude, France, 43100
        • Rezo Camsp
      • Bron, France, 69677
        • Hopital Femme, Mère, Enfant
      • Caen, France, 14000
        • CHU de Caen
      • Cahors, France, 46000
        • CH Cahors
      • Cahors, France, 46000
        • CMPP de Cahors
      • Calais, France, 62107
        • CH de Calais
      • Carcassonne, France, 11000
        • CH de Carcassonne
      • Castres, France, 81100
        • CH Castres - Hôpital du pays d'Autan
      • Chalon-sur-Saône, France, 71100
        • CH Chalon sur Saone - William Morey
      • Chambéry, France, 73000
        • Réseau Eclaur
      • Chambéry, France, 73011
        • CH Métropole Savoie
      • Charleville-Mézières, France, 08100
        • CAMSP de Charleville Mézières
      • Clermont-Ferrand, France, 63000
        • CHU Estaing
      • Colmar, France, 68024
        • Centre Hospitalier de Colmar
      • Compiègne, France, 60200
        • CH Compiègne
      • Contamine-sur-Arve, France, 74130
        • CH Alpes Leman
      • Corbeil, France, 91106
        • Ch Sud Francilien
      • Creil, France, 60109
        • CH Creil
      • Dax, France, 40100
        • CAMSP de Dax
      • Dijon, France, 21079
        • Chu Dijon - Hopital Du Bocage
      • Douai, France, 59507
        • CH de DOUAI
      • Espaly-Saint-Marcel, France, 43000
        • CAMSP Espaly
      • Essey-lès-Nancy, France, 54270
        • SCM Maison de l'enfant
      • Forbach, France, 57600
        • Hôpital de Forbach
      • Grenoble, France, 38043
        • CHU Grenoble / Réseau Naitre et Devenir
      • Haguenau, France, 67500
        • Centre Hospitalier de Haguenau
      • Laon, France, 02100
        • CH Laon
      • Le Mans, France, 72000
        • CHU Le Mans
      • Lens, France, 62307
        • CH de Lens
      • Lille, France, 59037
        • CHRU de Lille
      • Lille, France, 59000
        • Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille
      • Limoges, France, 87042
        • Hôpital Mère-Enfant de Limoges
      • Lorient, France, 56100
        • CAMSP, CHU de Lorient
      • Lyon, France, 69317
        • Hôpital de la Croix Rousse
      • Marseille, France, 13015
        • CHU Hopital Nord
      • Marseille, France, 13385
        • CHU de la Conception
      • Maubeuge, France, 59600
        • CH de Maubeuge
      • Metz, France, 57085
        • Hôpital de Mercy - CHR Metz Thionville
      • Metz-Tessy, France, 74370
        • CH Annecy Genevois
      • Mont-de-Marsan, France, 40024
        • Centre Hospitalier de Mont de Marsan
      • Montauban, France, 82000
        • CAMSP "l'Escabelle" Montauban
      • Montauban, France, 82000
        • CH Montauban
      • Montivilliers, France, 76290
        • GHH Havre - Hôpital Jacque Monod
      • Montpellier, France, 34000
        • CHU de Montpellier
      • Montpellier, France, 34295
        • CAMSP - CHU Saint-Eloi
      • Mulhouse, France, 68100
        • Centre Hospitalier de Mulhouse
      • Mâcon, France, 71000
        • CH Mâcon
      • Nancy, France, 54000
        • CHRU de Nancy (Maternité)
      • Nancy, France, 54000
        • CHRU de Nancy (Neuro-pédiatrie)
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France, 06200
        • CHU Hôpital l'Archet
      • Nîmes, France, 30029
        • CHU de Nîmes - Hôpital Carémeau
      • Orléans, France, 45000
        • CHR Orleans
      • Paris, France, 75012
        • Hopital Armand Trousseau
      • Paris, France, 75015
        • CIC Necker
      • Pau, France, 64000
        • Centre Hospitalier De Pau
      • Perpignan, France, 66046
        • CHG de Perpignan (CAMSP)
      • Périgueux, France, 24016
        • CAMSP de Périgueux
      • Reims, France, 51100
        • CHU de Reims / CAMSP
      • Rennes, France, 35033
        • CAMSP, CHU de Rennes
      • Rodez, France, 12027
        • CH Rodez - Jacques Puel
      • Roubaix, France, 59100
        • CH de Roubaix
      • Rouen, France, 76000
        • CHU de Rouen - Pavillon Mère et enfant
      • Saint-Brieuc, France, 22027
        • CAMSP de Saint Brieuc
      • Saint-Pierre, France, 97448
        • CHU Sud Réunion
      • Saint-Priest-en-Jarez, France, 42270
        • CHU St Etienne / Réseau HELENA
      • Saint-Quentin, France, 02100
        • CH Saint Quentin
      • Strasbourg, France, 67200
        • Centre Hospitalier Hautepierre
      • Tarbes, France, 65000
        • CH de Bigorre
      • Thionville, France, 57100
        • CAMSP Thionville
      • Thionville, France, 57100
        • Hôpital Bel Air Thionville - CHR Metz Thionville
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital des Enfants
      • Toulouse, France, 31082
        • Clinique Ambroise Pare
      • Tours, France, 37044
        • CHRU de Tours -Hôpital Clocheville
      • Troyes, France, 10000
        • CAMSP de Troyes
      • Valence, France, 26000
        • CH Valence
      • Valenciennes, France, 59322
        • Ch de Valenciennes
      • Vannes, France, 56000
        • CH de Vannes
      • Villefranche-sur-Saône, France, 69655
        • CH Villefranche sur Saone
      • Épinal, France, 88021
        • Hôpital d'Epinal
  • French Guiana
      • Cayenne, French Guiana
        • CH Andrée Rosemon
      • Saint-Laurent-du-Maroni, French Guiana
        • CH de l'Ouest Guyanais
  • Guadeloupe
      • Basse-Terre, Guadeloupe
        • CAMSP Basse-Terre
      • Les Abymes, Guadeloupe
        • CHU Pointre à Pitre
  • Reunion
      • Saint-Denis, Reunion
        • CAMSP Nord-ASFA Sainte Clotilde
      • Saint-Denis, Reunion
        • CHU Felix Guyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Preterm children included at birth in the EPIPAGE 2 cohort or in complementary studies whose famillies agree to participate to EPIPAGE 2 follow up (4600 children) + 600 children born at term and participating to the Elfe cohort (French longitudinal study of children)

Description

Inclusion Criteria:

  • initially included in EPIPAGE 2 cohort or complementary studies or Elfe cohort study
  • family agreement to participate to cohort follow up
  • informed consent form signed by both parents
  • affiliated to social security system

Exclusion Criteria:

  • parental refusal
  • not affiliated to any social security system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health disorders assessed by medical exam
Time Frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
5 years 5 months- 5 years 11 months
Motor disorders assessed by medical exam
Time Frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
5 years 5 months- 5 years 11 months
Cognitive disorders assessed by psychological testing
Time Frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
5 years 5 months- 5 years 11 months
Behavioural disorders by psychological testing
Time Frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
5 years 5 months- 5 years 11 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in medical practices collected by questionnaire
Time Frame: 5 years 5 months- 5 years 11 months
5 years 5 months- 5 years 11 months
Changes in organization of care collected by questionnaire
Time Frame: 5 years 5 months- 5 years 11 months
5 years 5 months- 5 years 11 months
Set up a DNA Biobank by saliva samples collection
Time Frame: 5 years 5 months- 5 years 11 months
5 years 5 months- 5 years 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2016

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C15-95
  • IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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