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van CCT (UK)

van CCT (UK)

EURAP & Development

- candidate number19526
- NTR NumberNTR4800
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2014
- Secondary IDsNL45505.018.13 METC AMC
- Public TitleEURAP & Development
- Scientific TitleChildren exposed to antiepileptic drugs in utero: developmental and behavioral effects in primary school children
- ACRONYMEURAP- NCEP: Eurapean Register of Antiepileptic Drugs and Pregnancy - Neurocognitive extension protocol
- hypothesisChildren exposed to antiepileptic drugs in utero are at higher risk for congenital malformations such as cardiac disease or spina bifida. Long-term effects on child neurocognitive and behavioral outcome are however hardly known.
Purpose of the study is to investigate neurocognitive and behavioral development in children of mothers with epilepsy, primary school age, and who were exposed to anti-epileptic drugs (carbamazepine, lamotrigine, valproate or levetiracetam) in utero. Design of the study is prospective, observational and longitudinal. The study consists of two measurement waves: T1, when children are aged 6/7 years and T2, when children are aged 8/9 years. Between T1 and T2 are two years. Children, mothers and fathers are asked to participate in the research by conducting neuropsychological tests and questionnaires.

This study is partly based on the neurocognitive extension protocol (NCEP) and contributes to international knowledge on long term effects of exposure to antiepileptic drugs in utero.
- Healt Condition(s) or Problem(s) studiedChildren, Epilepsy, Antiepileptics
- 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
-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 minimize the possible selection bias
- written informed consent will be required from the mother and /or father
-exposure of the child to Carbamazepine (CBZ), Lamotrigine (LTG), Valproate (VPA) or Levetiracetam (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 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate1-okt-2019
- Target number of participants260
- InterventionsNeuropsychological testing

260 children (260 mothers and 260 fathers)

(test leaders will be blinded for type of antiepileptic drug taken by the mother with epilepsy during pregnancy)
- Primary outcomePrimary 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 outcomeParenting stress, quality of parent child relationship, and parenting.
- TimepointsChildren exposed to antiepileptic drugs in utero and their mothers and fathers will get a neuropsychological assessment when the child is 6/7 years of age (T1) and again two years later when the child is 8/9 years of age. The neuropsychological assessment consists of an intelligence test for both children (Wechsler Intelligence Scale for Children: WISC-II-NL ) and mothers and fathers (Wechsler Adult Intelligence Scale: WAIS-III-NL). Neurocognitive assessments for the child (A Developmental NEuroPSYchological Assessment: NEPSY-II-NL, Peabody Picture Vocabulary Test: PPVT-III-NL, verbal fluency test: Lindeboom ) and behavioral questionnaires (Child Behavior Checklist: CBCL, Sociaal Emotionele Vragenlijst: SEV) and parenting questionnaires (Vragenlijsten Gezin & Opvoeding: VG&O, Ouder en kind interactie vragenlijst: OKIV-R) for parents.
- Trial web site
- statusplanned
- Sponsor/Initiator SEIN, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Panta Rhei
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-sep-2014 - 15-okt-2014

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