EURAP & Development
- Conditions
- Children of mothers with epilepsy exposed to antiepileptic drugs in utero
- Registration Number
- NL-OMON27933
- Lead Sponsor
- Stichting Epilepsie Instellingen Nederland (SEIN) / University of Amsterdam (UvA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 260
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary study parameters are: (1) Verbal IQ, Performal IQ, Total IQ (Intelligence: parents and child), attention, language skills, visuospatial skills, fine motor skills, memory recall and learning (cognitive skills) and social perception (theory of mind and affect recognition , word finding difficulties and receptive vocabulary. (2) Child psychiatric outcome, child behavioral outcome (including anxiety and depression), ADHD and autism.
- Secondary Outcome Measures
Name Time Method Parenting stress, quality of parent child relationship, and parenting.