EPIPAGE2 Cohort Study Follow up at Five and a Half Years

NCT ID: NCT03078439

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-02

Study Completion Date

2018-01-08

Brief Summary

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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.

Detailed Description

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Conditions

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Very Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Medical and neuropsychological assessments

Assessment of health status and development will be performed in specific centers at 5 and a half years. This check-up includes a complete medical examination to look for visual, hearing, motor impairment and health problems, and psychological tests using standardized tools (WPPSI IV ((Wechsler Preschool and Primary Scales Intelligence)) and NEPSY 2 tests) to assess cognitive development of very preterm children.

A parental questionnaire will be fulfilled to investigate family's social conditions, maternal health, autism spectrum disorders (Social Communication Questionnaire), the child's quality of life and behavioral development (Strengths and Difficulties Questionnaire).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de Forbach

Forbach, , France

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Centre Hopsitalier d'Agen

Agen, , France

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CAMSP Albi

Albi, , France

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CHU Amiens

Amiens, , France

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CHU d'Angers

Angers, , France

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CH d'Arras

Arras, , France

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CAMSP Auch

Auch, , France

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Centre Hospitalier Côte Basque

Bayonne, , France

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CH Beauvais

Beauvais, , France

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CHU Jean Minjoz

Besançon, , France

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Centre Hospitalier de Bordeaux

Bordeaux, , France

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CH Bourg en Bresse

Bourg-en-Bresse, , France

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CHU de Brest

Brest, , France

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Rezo Camsp

Brioude, , France

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Hopital Femme, Mère, Enfant

Bron, , France

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CHU de Caen

Caen, , France

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CH Cahors

Cahors, , France

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CMPP de Cahors

Cahors, , France

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CH de Calais

Calais, , France

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CH de Carcassonne

Carcassonne, , France

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CH Castres - Hôpital du pays d'Autan

Castres, , France

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CH Chalon sur Saone - William Morey

Chalon-sur-Saône, , France

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Réseau Eclaur

Chambéry, , France

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CH Métropole Savoie

Chambéry, , France

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CAMSP de Charleville Mézières

Charleville-Mézières, , France

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CHU Estaing

Clermont-Ferrand, , France

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Centre Hospitalier de Colmar

Colmar, , France

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CH Compiègne

Compiègne, , France

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CH Alpes Leman

Contamine-sur-Arve, , France

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CH Sud Francilien

Corbeil, , France

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CH Creil

Creil, , France

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CAMSP de Dax

Dax, , France

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CHU Dijon - Hôpital du Bocage

Dijon, , France

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CH de Douai

Douai, , France

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CAMSP Espaly

Espaly-Saint-Marcel, , France

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SCM Maison de l'enfant

Essey-lès-Nancy, , France

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Hôpital d'Epinal

Épinal, , France

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CHU Grenoble / Réseau Naitre et Devenir

Grenoble, , France

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Centre Hospitalier de Haguenau

Haguenau, , France

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CH Laon

Laon, , France

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CHU Le Mans

Le Mans, , France

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CH de Lens

Lens, , France

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Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, , France

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CHRU de Lille

Lille, , France

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Hôpital Mère-Enfant de Limoges

Limoges, , France

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CAMSP, CHU de Lorient

Lorient, , France

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Hopital de la Croix Rousse

Lyon, , France

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CHU Hôpital Nord

Marseille, , France

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CHU de la Conception

Marseille, , France

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CH de Maubeuge

Maubeuge, , France

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CH Mâcon

Mâcon, , France

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Hôpital de Mercy - CHR Metz Thionville

Metz, , France

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CH Annecy Genevois

Metz-Tessy, , France

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Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, , France

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CAMSP "l'Escabelle" Montauban

Montauban, , France

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CH Montauban

Montauban, , France

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GHH Havre - Hôpital Jacque Monod

Montivilliers, , France

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CHU de Montpellier

Montpellier, , France

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CAMSP - CHU Saint-Eloi

Montpellier, , France

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Centre Hospitalier de Mulhouse

Mulhouse, , France

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CHRU de Nancy (Maternité)

Nancy, , France

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CHRU de Nancy (Neuro-pédiatrie)

Nancy, , France

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CHU de Nantes

Nantes, , France

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CHU Hôpital l'Archet

Nice, , France

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CHU de Nimes - Hôpital Caremeau

Nîmes, , France

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CHR Orléans

Orléans, , France

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Hôpital Armand Trousseau

Paris, , France

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CIC Necker

Paris, , France

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Centre Hospitalier de Pau

Pau, , France

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CHG de Perpignan (CAMSP)

Perpignan, , France

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CAMSP de Périgueux

Périgueux, , France

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CHU de Reims / CAMSP

Reims, , France

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CAMSP, CHU de Rennes

Rennes, , France

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CH Rodez - Jacques Puel

Rodez, , France

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CH de Roubaix

Roubaix, , France

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CHU de Rouen - Pavillon Mère et enfant

Rouen, , France

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CAMSP de Saint Brieuc

Saint-Brieuc, , France

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CHU Sud Réunion

Saint-Pierre, , France

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CHU St Etienne / Réseau HELENA

Saint-Priest-en-Jarez, , France

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CH Saint Quentin

Saint-Quentin, , France

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Centre Hospitalier Hautepierre

Strasbourg, , France

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CH de Bigorre

Tarbes, , France

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CAMSP Thionville

Thionville, , France

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Hôpital Bel Air Thionville - CHR Metz Thionville

Thionville, , France

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CHU de Toulouse - Hôpital des enfants

Toulouse, , France

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Clinique Ambroise Paré

Toulouse, , France

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CHRU de Tours -Hôpital Clocheville

Tours, , France

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CAMSP de Troyes

Troyes, , France

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CH Valence

Valence, , France

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CH de Valenciennes

Valenciennes, , France

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CH de Vannes

Vannes, , France

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CH Villefranche sur Saone

Villefranche-sur-Saône, , France

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CH Andrée Rosemon

Cayenne, , French Guiana

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CH de l'Ouest Guyanais

Saint-Laurent-du-Maroni, , French Guiana

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CAMSP Basse-Terre

Basse-Terre, , Guadeloupe

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CHU Pointre à Pitre

Les Abymes, , Guadeloupe

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CAMSP Nord-ASFA Sainte Clotilde

Saint-Denis, , Reunion

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CHU Felix Guyon

Saint-Denis, , Reunion

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Countries

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France French Guiana Guadeloupe Reunion

References

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Guellec I, Brunet A, Lapillonne A, Taine M, Torchin H, Favrais G, Gascoin G, Simon L, Heude B, Scherdel P, Kayem G, Delorme P, Jarreau PH, Ancel PY. Birth weight and head circumference discordance and outcome in preterms: results from the EPIPAGE-2 cohort. Arch Dis Child. 2024 May 17;109(6):503-509. doi: 10.1136/archdischild-2023-326336.

Reference Type DERIVED
PMID: 38408861 (View on PubMed)

Related Links

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Other Identifiers

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IDRCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

C15-95

Identifier Type: -

Identifier Source: org_study_id

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