EPIPAGE2 Cohort Study Follow up at Five and a Half Years

Very Preterm Birth Clinical Trial

— EPIPAGE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078439
• Other study ID #: C15-95
• Secondary ID: IDRCB
• Status: Completed
• Start date: September 2, 2016
• Est. completion date: January 8, 2018

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3404
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Very Preterm Birth

Intervention

Other:
• 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).

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health disorders assessed by medical exam	According to gestational age at birth	5 years 5 months- 5 years 11 months
Primary	Motor disorders assessed by medical exam	According to gestational age at birth	5 years 5 months- 5 years 11 months
Primary	Cognitive disorders assessed by psychological testing	According to gestational age at birth	5 years 5 months- 5 years 11 months
Primary	Behavioural disorders by psychological testing	According to gestational age at birth	5 years 5 months- 5 years 11 months
Secondary	Changes in medical practices collected by questionnaire		5 years 5 months- 5 years 11 months
Secondary	Changes in organization of care collected by questionnaire		5 years 5 months- 5 years 11 months
Secondary	Set up a DNA Biobank by saliva samples collection		5 years 5 months- 5 years 11 months

External Links

•   Epipage 2 website