Clinical trial NCT03078439: EPIPAGE2 Cohort Study Follow up at Five and a Half Years
Official title: Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Preterm Birth
Keywords: very preterm birth
developmental disorders
health problems
prospective population-based cohort
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-03-13
Enrollment: 3404
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health disorders assessed by medical exam
timeFrame: 5 years 5 months- 5 years 11 months
measure: Motor disorders assessed by medical exam
timeFrame: 5 years 5 months- 5 years 11 months
measure: Cognitive disorders assessed by psychological testing
timeFrame: 5 years 5 months- 5 years 11 months
measure: Behavioural disorders by psychological testing
timeFrame: 5 years 5 months- 5 years 11 months
Secondary outcomes:
measure: Changes in medical practices collected by questionnaire
timeFrame: 5 years 5 months- 5 years 11 months
measure: Changes in organization of care collected by questionnaire
timeFrame: 5 years 5 months- 5 years 11 months
measure: Set up a DNA Biobank by saliva samples collection
timeFrame: 5 years 5 months- 5 years 11 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Hopsitalier d'Agen
city: Albi
country: France
facility: CAMSP Albi
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Arras
country: France
facility: CH d'Arras
city: Auch
country: France
facility: CAMSP Auch
city: Basse-Terre
country: France
facility: CAMSP Basse-Terre
city: Bayonne
country: France
facility: Centre Hospitalier Côte Basque
city: Beauvais
country: France
facility: CH Beauvais
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Centre Hospitalier de Bordeaux
city: Bourg-en-Bresse
country: France
facility: CH Bourg en Bresse
city: Brest
country: France
facility: CHU de Brest
city: Brioude
country: France
facility: Rezo Camsp
city: Bron
country: France
facility: Hopital Femme, Mère, Enfant
city: Caen
country: France
facility: CHU de Caen
city: Cahors
country: France
facility: CH Cahors
city: Cahors
country: France
facility: CMPP de Cahors
city: Calais
country: France
facility: CH de Calais
city: Carcassonne
country: France
facility: CH de Carcassonne
city: Castres
country: France
facility: CH Castres - Hôpital du pays d'Autan
city: Cayenne
country: France
facility: CH Andrée Rosemon
city: Chalon Sur Soane
country: France
facility: CH Chalon sur Saone - William Morey
city: Chambery
country: France
facility: CH Métropole Savoie
city: Chambéry
country: France
facility: Réseau Eclaur
city: Charleville Mézières
country: France
facility: CAMSP de Charleville Mézières
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Colmar
country: France
facility: Centre Hospitalier de Colmar
city: Compiègne
country: France
facility: CH Compiègne
city: Contamine-sur-Arve
country: France
facility: CH Alpes Leman
city: Corbeil
country: France
facility: CH Sud Francilien
city: Creil
country: France
facility: CH Creil
city: Dax
country: France
facility: CAMSP de Dax
city: Dijon
country: France
facility: CHU Dijon - Hôpital du Bocage
city: Douai
country: France
facility: CH de Douai
city: Elesme
country: France
facility: CH de Maubeuge
city: Epinal
country: France
facility: Hôpital d'Epinal
city: Espaly
country: France
facility: CAMSP Espaly
city: Essey les Nancy
country: France
facility: SCM Maison de l'enfant
city: Forbach
country: France
facility: Hôpital de Forbach
city: Gernoble
country: France
facility: CHU Grenoble / Réseau Naitre et Devenir
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Laon
country: France
facility: CH Laon
city: Le Mans
country: France
facility: CHU Le Mans
city: Lens
country: France
facility: CH de Lens
city: Les Abymes
country: France
facility: CHU Pointre à Pitre
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: Hôpital Mère-Enfant de Limoges
city: Lorient
country: France
facility: CAMSP, CHU de Lorient
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: CHU Hôpital Nord
city: Marseille
country: France
facility: CHU de la Conception
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Metz
country: France
facility: Hôpital de Mercy - CHR Metz Thionville
city: Mont de Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan
city: Montauban
country: France
facility: CAMSP "l'Escabelle" Montauban
city: Montauban
country: France
facility: CH Montauban
city: Montivilliers
country: France
facility: GHH Havre - Hôpital Jacque Monod
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montpellier
country: France
facility: CAMSP - CHU Saint-Eloi
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Mâcon
country: France
facility: CH Mâcon
city: Nancy
country: France
facility: CHRU de Nancy (Maternité)
city: Nancy
country: France
facility: CHRU de Nancy (Neuro-pédiatrie)
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU Hôpital l'Archet
city: Nîmes
country: France
facility: CHU de Nimes - Hôpital Caremeau
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: CIC Necker
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perpignan
country: France
facility: CHG de Perpignan (CAMSP)
city: Périgueux
country: France
facility: CAMSP de Périgueux
city: Reims
country: France
facility: CHU de Reims / CAMSP
city: Rennes
country: France
facility: CAMSP, CHU de Rennes
city: Reunion
country: France
facility: CHU Felix Guyon
city: Rodez
country: France
facility: CH Rodez - Jacques Puel
city: Roubaix
country: France
facility: CH de Roubaix
city: Rouen
country: France
facility: CHU de Rouen - Pavillon Mère et enfant
city: Saint Brieuc
country: France
facility: CAMSP de Saint Brieuc
city: Saint Denis De La Réunion
country: France
facility: CAMSP Nord-ASFA Sainte Clotilde
city: Saint Laurent Du Maroni
country: France
facility: CH de l'Ouest Guyanais
city: Saint Pierre
country: France
facility: CHU Sud Réunion
city: Saint Priesr En Jarez
country: France
facility: CHU St Etienne / Réseau HELENA
city: Saint Quentin
country: France
facility: CH Saint Quentin
city: Strasbourg
country: France
facility: Centre Hospitalier Hautepierre
city: Tarbes
country: France
facility: CH de Bigorre
city: Thionville
country: France
facility: CAMSP Thionville
city: Thionville
country: France
facility: Hôpital Bel Air Thionville - CHR Metz Thionville
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital des enfants
city: Toulouse
country: France
facility: Clinique Ambroise Paré
city: Tours
country: France
facility: CHRU de Tours -Hôpital Clocheville
city: Troyes
country: France
facility: CAMSP de Troyes
city: Valence
country: France
facility: CH Valence
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Vannes
country: France
facility: CH de Vannes
city: Villefranche-sur-Saône
country: France
facility: CH Villefranche sur Saone
Study officials:
References: