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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41629

Enrollment

780

Registered

2014-09-16

Start date

2015-01-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gedragsproblemen development mental health

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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 (kind), word finding difficulties and receptive vocabulary (kind). (2). Child psychiatric outcome, child behavioral outcome (including anxiety and depression), ADHD, and autism.	—

Measure

Time frame

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 (kind), word finding difficulties and receptive vocabulary (kind). (2). Child psychiatric outcome, child behavioral outcome (including anxiety and depression), ADHD, and autism.

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Secondary

Measure	Time frame
Parenting stress, quality of parent-child relationship, parental behavior, and parenting	—

Countries

Netherlands

Outcome results