EPIPAGE2 Cohort Study Follow up at Five and a Half Years
EPIPAGE2
Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years
2 other identifiers
observational
3,404
3 countries
96
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2016
CompletedFirst Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2018
CompletedApril 15, 2026
August 1, 2021
1.4 years
November 8, 2016
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Health disorders assessed by medical exam
According to gestational age at birth
5 years 5 months- 5 years 11 months
Motor disorders assessed by medical exam
According to gestational age at birth
5 years 5 months- 5 years 11 months
Cognitive disorders assessed by psychological testing
According to gestational age at birth
5 years 5 months- 5 years 11 months
Behavioural disorders by psychological testing
According to gestational age at birth
5 years 5 months- 5 years 11 months
Secondary Outcomes (3)
Changes in medical practices collected by questionnaire
5 years 5 months- 5 years 11 months
Changes in organization of care collected by questionnaire
5 years 5 months- 5 years 11 months
Set up a DNA Biobank by saliva samples collection
5 years 5 months- 5 years 11 months
Interventions
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).
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- parental refusal
- not affiliated to any social security system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
Centre Hopsitalier d'Agen
Agen, 47000, France
CAMSP Albi
Albi, 82000, France
CHU Amiens
Amiens, 80000, France
CHU d'Angers
Angers, 49933, France
CH d'Arras
Arras, 62022, France
CAMSP Auch
Auch, 32000, France
Centre Hospitalier Côte Basque
Bayonne, 64100, France
CH Beauvais
Beauvais, 40319, France
CHU Jean Minjoz
Besançon, 25030, France
Centre Hospitalier de Bordeaux
Bordeaux, 33000, France
CH Bourg en Bresse
Bourg-en-Bresse, 01012, France
CHU de Brest
Brest, 29609, France
Rezo Camsp
Brioude, 43100, France
Hopital Femme, Mère, Enfant
Bron, 69677, France
CHU de Caen
Caen, 14000, France
CH Cahors
Cahors, 46000, France
CMPP de Cahors
Cahors, 46000, France
CH de Calais
Calais, 62107, France
CH de Carcassonne
Carcassonne, 11000, France
CH Castres - Hôpital du pays d'Autan
Castres, 81100, France
CH Chalon sur Saone - William Morey
Chalon-sur-Saône, 71100, France
Réseau Eclaur
Chambéry, 73000, France
CH Métropole Savoie
Chambéry, 73011, France
CAMSP de Charleville Mézières
Charleville-Mézières, 08100, France
CHU Estaing
Clermont-Ferrand, 63000, France
Centre Hospitalier de Colmar
Colmar, 68024, France
CH Compiègne
Compiègne, 60200, France
CH Alpes Leman
Contamine-sur-Arve, 74130, France
CH Sud Francilien
Corbeil, 91106, France
CH Creil
Creil, 60109, France
CAMSP de Dax
Dax, 40100, France
CHU Dijon - Hôpital du Bocage
Dijon, 21079, France
CH de Douai
Douai, 59507, France
CAMSP Espaly
Espaly-Saint-Marcel, 43000, France
SCM Maison de l'enfant
Essey-lès-Nancy, 54270, France
Hôpital d'Epinal
Épinal, 88021, France
Hôpital de Forbach
Forbach, 57600, France
CHU Grenoble / Réseau Naitre et Devenir
Grenoble, 38043, France
Centre Hospitalier de Haguenau
Haguenau, 67500, France
CH Laon
Laon, 02100, France
CHU Le Mans
Le Mans, 72000, France
CH de Lens
Lens, 62307, France
Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, 59000, France
CHRU de Lille
Lille, 59037, France
Hôpital Mère-Enfant de Limoges
Limoges, 87042, France
CAMSP, CHU de Lorient
Lorient, 56100, France
Hopital de la Croix Rousse
Lyon, 69317, France
CHU Hôpital Nord
Marseille, 13015, France
CHU de la Conception
Marseille, 13385, France
CH de Maubeuge
Maubeuge, 59600, France
CH Mâcon
Mâcon, 71000, France
Hôpital de Mercy - CHR Metz Thionville
Metz, 57085, France
CH Annecy Genevois
Metz-Tessy, 74370, France
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40024, France
CAMSP "l'Escabelle" Montauban
Montauban, 82000, France
CH Montauban
Montauban, 82000, France
GHH Havre - Hôpital Jacque Monod
Montivilliers, 76290, France
CHU de Montpellier
Montpellier, 34000, France
CAMSP - CHU Saint-Eloi
Montpellier, 34295, France
Centre Hospitalier de Mulhouse
Mulhouse, 68100, France
CHRU de Nancy (Maternité)
Nancy, 54000, France
CHRU de Nancy (Neuro-pédiatrie)
Nancy, 54000, France
CHU de Nantes
Nantes, 44093, France
CHU Hôpital l'Archet
Nice, 06200, France
CHU de Nimes - Hôpital Caremeau
Nîmes, 30029, France
CHR Orléans
Orléans, 45000, France
Hôpital Armand Trousseau
Paris, 75012, France
CIC Necker
Paris, 75015, France
Centre Hospitalier de Pau
Pau, 64000, France
CHG de Perpignan (CAMSP)
Perpignan, 66046, France
CAMSP de Périgueux
Périgueux, 24016, France
CHU de Reims / CAMSP
Reims, 51100, France
CAMSP, CHU de Rennes
Rennes, 35033, France
CH Rodez - Jacques Puel
Rodez, 12027, France
CH de Roubaix
Roubaix, 59100, France
CHU de Rouen - Pavillon Mère et enfant
Rouen, 76000, France
CAMSP de Saint Brieuc
Saint-Brieuc, 22027, France
CHU Sud Réunion
Saint-Pierre, 97448, France
CHU St Etienne / Réseau HELENA
Saint-Priest-en-Jarez, 42270, France
CH Saint Quentin
Saint-Quentin, 02100, France
Centre Hospitalier Hautepierre
Strasbourg, 67200, France
CH de Bigorre
Tarbes, 65000, France
CAMSP Thionville
Thionville, 57100, France
Hôpital Bel Air Thionville - CHR Metz Thionville
Thionville, 57100, France
CHU de Toulouse - Hôpital des enfants
Toulouse, 31059, France
Clinique Ambroise Paré
Toulouse, 31082, France
CHRU de Tours -Hôpital Clocheville
Tours, 37044, France
CAMSP de Troyes
Troyes, 10000, France
CH Valence
Valence, 26000, France
CH de Valenciennes
Valenciennes, 59322, France
CH de Vannes
Vannes, 56000, France
CH Villefranche sur Saone
Villefranche-sur-Saône, 69655, France
CH Andrée Rosemon
Cayenne, French Guiana
CH de l'Ouest Guyanais
Saint-Laurent-du-Maroni, French Guiana
CAMSP Basse-Terre
Basse-Terre, Guadeloupe
CHU Pointre à Pitre
Les Abymes, Guadeloupe
CAMSP Nord-ASFA Sainte Clotilde
Saint-Denis, Reunion
CHU Felix Guyon
Saint-Denis, Reunion
Related Publications (2)
Walter-Nicolet E, Marchand-Martin L, Morgan AS, Kaminski M, Benhammou V, Ancel PY, Tourneux P, Pierrat V, Durrmeyer X. Neurodevelopmental outcomes at five years in children born very preterm (24-31 weeks) exposed to opioids with or without midazolam: results from the French nationwide EPIPAGE-2 cohort study. Lancet Reg Health Eur. 2025 Feb 18;52:101242. doi: 10.1016/j.lanepe.2025.101242. eCollection 2025 May.
PMID: 40060937RESULTGuellec 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.
PMID: 38408861RESULT
Related Links
Biospecimen
DNA from saliva samples collected from 5 years and a half children
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2016
First Posted
March 13, 2017
Study Start
September 2, 2016
Primary Completion
January 8, 2018
Study Completion
January 8, 2018
Last Updated
April 15, 2026
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share