NL-OMON27933
Not yet recruiting
Not Applicable
Children exposed to antiepileptic drugs in utero: developmental and behavioral effects in primary school children
Stichting Epilepsie Instellingen Nederland (SEIN) / University of Amsterdam (UvA)0 sites260 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Children of mothers with epilepsy exposed to antiepileptic drugs in utero
- Sponsor
- Stichting Epilepsie Instellingen Nederland (SEIN) / University of Amsterdam (UvA)
- Enrollment
- 260
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •the study will aim at enrolling mother – child pairs meeting the eligibility criteria outlined below and enrolled semi\-prospectively in the EURAP core study
- •\-eligibility must be checked with the central registry in Milan before enrolling the mother\-child pair for NCEP (to avoid enrolling cases that have been rejected by the central registry prior to NCEP) for minimizing selection bias
Exclusion Criteria
- •\-Mother’s inability to take care of the child (e.g. due to severity of epilepsy)
- •\-known chromosomal/genetic syndromes of the child or prematurity (gestational age less than 37 weeks)
Outcomes
Primary Outcomes
Not specified
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