Very Preterm Birth
Conditions
Keywords
very preterm birth, developmental disorders, health problems, prospective population-based cohort
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.
Interventions
OTHERMedical 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).
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
France, French Guiana, Guadeloupe, Reunion
Outcome results
None listed