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EPIPAGE2 Cohort Study Follow up at Five and a Half Years

NCT03078439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3404

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Very Preterm Birth

Interventions

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).

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-02
Primary Completion
2018-01-08
Completion
2018-01-08

Countries

  • France
  • French Guiana
  • Guadeloupe
  • Reunion

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078439 on ClinicalTrials.gov