EPIPAGE2 Cohort Study Follow up at Five and a Half Years

Study Overview
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Brief Summary
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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.

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

Conditions
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Very Preterm Birth

Intervention / Treatment
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* Other: Medical and neuropsychological assessments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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very preterm birth, developmental disorders, health problems, prospective population-based cohort