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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's enrollment of 3,404 is above the median of 216 across 74 observational studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Sep 2016 to primary completion in Jan 2018, 16 months.
Of 27 observational studies under Developmental Disabilities, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 102. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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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