Purpose of the study is to investigate neurocognitive and behavioral development in children of morthers with epilepsy, primary school age, and who were exposed to anti-epileptic drugs in utero. Primary research questions are: 1. what is the nature…
ID
Source
Brief title
Condition
- Other condition
- Cognitive and attention disorders and disturbances
- Family issues
Synonym
Health condition
gedragsproblemen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Parenting stress, quality of parent-child relationship, parental behavior, and
parenting
Background summary
Children exposed to antiepileptic drugs in utero are at higher risk for
congenital malformations such as cardiac disease or spinia bifida. Long-terms
effects on child neurocognitive and behavioral outcome are however hardly
known.
Study objective
Purpose of the study is to investigate neurocognitive and behavioral
development in children of morthers with epilepsy, primary school age, and who
were exposed to anti-epileptic drugs in utero. Primary research questions are:
1. what is the nature and severity of developmental problems (cognitive and
behavioral) in children at ages 6/7 and at follow-up at ages 8/9? 2. Wat is
the nature and severity of child developmental problems in children at ages 8/9
when compared to children at ages 6/7? 3. Which factors explain developmental
problems in these children?
Study design
Design of the study is prospective, observational and longitudinal. The study
consists of two measurement waves: T1, if children are aged 6/7 years and T2,
if 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 (e.g., IQ test), and questionnaires (e.g. into
behavioral problems such as autism of attention deficit disorder and
parenting). The research is carried out at Epilepsy Institute in the
Netherlands Foundation (SEIN), department of Psychology.
Study burden and risks
The burden associated with participation is minimal. One appointment is made
with chidlren, mothers, and fathers: a visit of the family to the outpatient
clinic of SEIN. An second appointment with parents will be made to discuss the
results with parents. Associated risks are considered as minimal and the
research is nor painful neither invasive of nature. Parents and children are
asked prior to study inclusion for written informed consent.
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45505.018.13 |
| OMON | NL-OMON27933 |