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Clinical Trials/NL-OMON41629
NL-OMON41629
Completed
Not Applicable

Children exposed to antiepileptic drugs in utero: developmental and behavioral effects in primary school children - EURAP & Development

niversiteit van Amsterdam0 sites780 target enrollmentTBD
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Conditionsgedragsproblemendevelopmentmental health1000984110016214

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
gedragsproblemen
Sponsor
niversiteit van Amsterdam
Enrollment
780
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
niversiteit van Amsterdam

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 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

Outcomes

Primary Outcomes

Not specified

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ISRCTN72533351Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)