Neurodevelopment of Babies Born to Mothers with Epilepsy (NaME)Study
Research type
Research Study
Full title
Neurodevelopment of Babies Born to Mothers with Epilepsy (NaME)Study
IRAS ID
143279
Contact name
Rebecca Bromley
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
4 years, 3 months, 25 days
Research summary
Research Summary
Currently little is done routinely to detect neurodevelopmental problems in children following exposure to medications in the womb. Therefore there is a lack of information for the majority of medications, meaning that treatment is unlikely to be optimised for either maternal or child safety. Typical methods for assessing neurodevelopment involve clinician completed assessments of the child, which are costly and time consuming. This study aims to investigate whether parental reporting of child neurodevelopment on questionnaires will be a useful and reliable method to assess the neurodevelopment of children following exposure in the womb to medications.
There is evidence that certain antiepileptic drugs (AEDs) are associated with poorer neurodevelopmental outcomes and therefore offer a way to investigate the reliability of parental reporting methods. Further, there is limited evidence regarding the neurodevelopment of children exposed to newer antiepileptic drugs, which are now commonly used in women in their childbearing years. This study will also provide evidence regarding the neurodevelopment of children exposed to both newer and established antiepileptic drugs.Women with epilepsy, who are in their first or second trimester, will be invited participate. Demographics and health information will be collected during gestation. At 12 months of age the parent will complete the Ages and Stages Questionnaire (ASQ) and the Vineland Adaptive Behaviour Scale (VABS). At 24 months of age the child will be assessed using the Bayley Scales of Infant and Toddler Development (Bayley Scales) and reassessed with the ASQ and VABS. Statistical analysis will investigate reliability of the parental reported measures in comparison to scores on the clinician completed Bayley Scales.
The results of this study be presented through both verbal presentations and journal publication. Additionally, the results of this study will be made available to beneficiaries of this research including charities, regulators and NHS professionals.
Summary of Results
Background Exposure to certain medications in the womb can place the developing child at a greater risk of physical and childhood developmental problems. Effects on development are not always apparent at birth and problems may go unnoticed for many years after a medication has received approval for use. This study was developed to investigate how we could reliably assess the development of large groups of children exposed to medications in the womb across large geographical regions.
Methods
To help us answer this question we recruited women with epilepsy who were taking antiseizure medications. This is a group of medications where certain medications have been associated with poorer developmental outcomes and therefore this is a critical group of medications to study.
Women were recruited if they were in their first or second trimester from 21 participating hospitals across the North West and North East of England and Northern Ireland. Information was collected during pregnancy about the participating women and their health. Birth information was recorded at the child’s birth. Questionnaires (Ages and Stages Questionnaire, 3rd Edition) and telephone interviews (Vinelands Adaptive Behavior Scale, 3rd Edition) were conducted with the parents when the child was 12 months old. At 24 months of age a researcher blinded to the medication history of the mother re administered the interviews and questionnaires but also completed a play based assessment (Bayley Scales of Infant and Toddler Development, 3rd Edition) to understand further the child’s development.
Results
Four hundred and four women were recruited and followed up. At two years of age 277 families completed the home visit. The results of this assessment did not find that children exposed to either lamotrigine or levetiracetam were at a greater risk of neurodevelopmental problems that children who were not exposed to medications. The questionnaires completed by the parents at the same time as the researcher assessment showed good comparability to the researcher led assessment and were able to detect children identified at risk of developmental delays.
Conclusions
Collecting the parental reports on development via self-completed questionnaires or view semi structured interview can offer a reliable method for large population screening within pharmacovigilance studies.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0193
Date of REC Opinion
22 Apr 2014
REC opinion
Favourable Opinion