Epi-Follow

• Research type

  Research Study

• Full title

  Epi-Follow: Investigating Long-Term Effects of Anti-Seizure Medications on Child Neurodevelopment

• IRAS ID

  338291

• Contact name

  Rebecca Bromley

• Contact email

  rebecca.bromley@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Duration of Study in the UK

  2 years, 6 months, 30 days

• Research summary

  Certain anti-seizure medications (ASMs) are known to carry a teratogenic risk and are associated with higher rates of impaired physical and neurodevelopmental outcomes in the children of women with epilepsy. However, there remains a considerable gap in our current knowledge regarding the risk/safety profile of the majority of ASMs when used during pregnancy, including commonly prescribed ASMs such as lamotrigine and levetiracetam.

  We will investigate the health and development of children who were exposed in utero to ASMs and whose mothers were enrolled in one of two previous funded NIHR cohorts, the Neurodevelopment of Babies Born to Mothers with Epilepsy (NaME) study (IRAS 143279), and the AntiEpileptic drug Monitoring in PREgnancy (EMPiRE) study (REC 11/WM/1064). We will also undertake a qualitative investigation to ensure women’s views on the potential long-term impact of ASM exposure on their child(ren)’s health and development are captured.

  Caregivers and their children (aged 8-14 years) who participated in either of the two previous studies will be contacted and invited to enrol in the current study either through their LCRN (EMPiRE participants) or the NaME Study Team (NaME participants). All participants will have a neuropsychological assessment with their child in the family home, the child’s school, or local participating NHS sites based on their preference. The assessment will take 2-3 hours.

  Women who participate will also be invited to take part in an optional interview to share their views and concerns on possible long-term effects of ASM exposure on their child(ren). A purposive, heterogenous, sampling strategy will be employed. Interviews (~45-60mins) will be conducted remotely or in-person (at home or participating NHS sites) with approximately 30-35 women at a date and time most convenient to them.

  Study duration will depend on which parts each participant opts-in for:
  -Part 1: up to 3 months
  -Part 1 and 2: up to 6 months

• REC name

  West of Scotland REC 5

• REC reference

  24/WS/0129

• Date of REC Opinion

  10 Oct 2024

• REC opinion

  Further Information Favourable Opinion