An observational study in Very Preterm Birth, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 98 sites in 4 countries. Open to participants aged 5 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational
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.
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)
Exclusion Criteria:
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).
Health disorders assessed by medical exam
According to gestational age at birth
Time frame: 5 years 5 months- 5 years 11 months
Motor disorders assessed by medical exam
According to gestational age at birth
Time frame: 5 years 5 months- 5 years 11 months
Cognitive disorders assessed by psychological testing
According to gestational age at birth
Time frame: 5 years 5 months- 5 years 11 months
Behavioural disorders by psychological testing
According to gestational age at birth
Time frame: 5 years 5 months- 5 years 11 months
Changes in medical practices collected by questionnaire
Time frame: 5 years 5 months- 5 years 11 months
Changes in organization of care collected by questionnaire
Time frame: 5 years 5 months- 5 years 11 months
Set up a DNA Biobank by saliva samples collection
Time frame: 5 years 5 months- 5 years 11 months
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France