Neurodevelopmental Outcomes in the Offspring of Males Taking Antiseizure Medication
The NOMAD study aims to determine whether paternal use of sodium valproate is associated with an increased risk of adverse neurodevelopmental outcomes in children. This follows guidance from the Medicines and Healthcare products Regulatory Authority (MHRA) restricting valproate use in men under 55, based on conflicting evidence from pre-clinical studies and European population data.
We will use the Electronic Data Research and Innovation Service (eDRIS) to conduct a population-based retrospective cohort study in Scotland, linking parental health records to child developmental data. Participants are children born in Scotland between 2010 and 2022 whose parents were dispensed antiseizure medications around the time of conception. No direct recruitment is required as we will use existing linked administrative health records, including birth records, prescribing data, and Child Health Surveillance Programme developmental assessments, all conducted within the eDRIS Safe Haven.
Our methods include record linkage and statistical analysis comparing developmental outcomes across four groups: children exposed to paternal sodium valproate, maternal sodium valproate, other antiseizure medications, and unexposed controls, covering approximately 280,000 births. Results will directly inform clinical practice and regulatory decision-making by the MHRA and European Medicines Agency.
Team
Co-Investigators
- Prof Craig Heath, Department of Neurology, NHS Greater Glasgow and Clyde, UK (Principal Investigator)
- Prof Colin McCowan, School of Medicine, University of St Andrews
- Dr Desy Nuryunarsih, School of Medicine, University of St Andrews
- Dr Rebecca Bromley, Paediatric Psychology Department, Royal Manchester Children’s Hospital, Manchester
- Dr Craig John, Department of Neurology, Belfast Health and Social Care Trust, Belfast, UK
- Dr Alex Marshall, School of Health and Wellbeing, University of Glasgow
Publications
Coming soon
Contact Us
If you have a question about the NOMAD study or would like further information, please email us at [email protected] and we will get back to you as soon as possible.