Children exposed to antiepileptic drugs in utero: developmental and behavioral effects in primary school childre

Completed

Conditions: gedragsproblemen
development
mental health
10009841
10016214

Registration Number: NL-OMON41629

Lead Sponsor: niversiteit van Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 780

Inclusion Criteria

*the study will aim at enrolling mother - child pairs meeting the eligibility criteria outlined below and enrolled semi-prospectively in the participating centres in the EURAP core study
*eligibility must be checked with the central registry in Milan (Dina Battino or Bibiana, email dbattino@istituto-besta.it) before enrolling the mother -child pair for NCEP (to avoid enrolling cases that have been rejected by the central registry prior to NCEP) for minimising selection bias
*every effort will be made to enroll all consecutive mother - child pairs and information about the reason for not enrolling will be recorded and analyzed to minimise the possible selection bias
*written informed consent will be required from the mother and /or father according to national legal requirements
*exposure of the child to CBZ, LTG, VPA or LEV monotherapy during the entire period from conception to birth
*exposed children are 6 / 7 years at T1
*exposed children are 8 / 9 years at T2

Exclusion Criteria

*mother*s inability to take care of the child (e.g. due to severity of the epilepsy)
*known chromosomal/genetic syndromes of the child or prematurity (gestational age less than 37 weeks)
*mother - child pairs in whom information to estimate the impact of factors other than AED exposure modifying significantly development of the child cannot be reliably assessed, i.e. is missing or unavailable

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters are: (1.) Verbal IQ, Performal IQ, Total IQ<br /><br>(Intelligence: parents and child), attention, language skills, visuospatial<br /><br>skills, fine motor skills, memory recall and learning (cognitive skills) and<br /><br>social perception (theory of mind and affect recognition (kind), word finding<br /><br>difficulties and receptive vocabulary (kind). (2). Child psychiatric outcome,<br /><br>child behavioral outcome (including anxiety and depression), ADHD, and autism. </p><br>

Secondary Outcome Measures