EPIPAGE2 Cohort Study Follow up at Five and a Half Years
- Conditions
- Very Preterm Birth
- Registration Number
- NCT03078439
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3404
- 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
- parental refusal
- not affiliated to any social security system
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health disorders assessed by medical exam 5 years 5 months- 5 years 11 months According to gestational age at birth
Motor disorders assessed by medical exam 5 years 5 months- 5 years 11 months According to gestational age at birth
Cognitive disorders assessed by psychological testing 5 years 5 months- 5 years 11 months According to gestational age at birth
Behavioural disorders by psychological testing 5 years 5 months- 5 years 11 months According to gestational age at birth
- Secondary Outcome Measures
Name Time Method Changes in medical practices 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 Changes in organization of care collected by questionnaire 5 years 5 months- 5 years 11 months
Trial Locations
- Locations (98)
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
Scroll for more (88 remaining)Centre Hopsitalier d'Agen🇫🇷Agen, France