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NCT Number: NCT03078439

EPIPAGE2 Cohort Study Follow up at Five and a Half Years

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.

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Key information

Conditions

Very Preterm Birth Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hopsitalier d'Agen, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical and neuropsychological assessments

Other

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).

Primary outcomes

  1. Health disorders assessed by medical exam

    Time frame: 5 years 5 months- 5 years 11 months

    According to gestational age at birth

  2. Motor disorders assessed by medical exam

    Time frame: 5 years 5 months- 5 years 11 months

    According to gestational age at birth

  3. Cognitive disorders assessed by psychological testing

    Time frame: 5 years 5 months- 5 years 11 months

    According to gestational age at birth

  4. Behavioural disorders by psychological testing

    Time frame: 5 years 5 months- 5 years 11 months

    According to gestational age at birth

Secondary outcomes

  1. Changes in medical practices collected by questionnaire

    Time frame: 5 years 5 months- 5 years 11 months

  2. Changes in organization of care collected by questionnaire

    Time frame: 5 years 5 months- 5 years 11 months

  3. Set up a DNA Biobank by saliva samples collection

    Time frame: 5 years 5 months- 5 years 11 months

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: EPIPAGE2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2017
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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