Neurodevelopment of babies born to mothers with epilepsy: a prospective observational cohort study

NaME Study Group, Rebecca L Bromley, Philip Bullen, Ellen Campbell, John Craig, Amy Ingham, Beth Irwin, Cerain Jackson, Teresa Kelly, James Morrow, Sarah Rushton, Marta García-Fiñana, David M Hughes, Janine Winterbottom, Amanda Wood, Laura M Yates, Jill Clayton-Smith

Research output: Contribution to journalArticlepeer-review


OBJECTIVE: Despite widespread monotherapy use of lamotrigine or levetiracetam during pregnancy, prospectively collected, blinded, child development data are still limited. The Neurodevelopment of babies born to mothers with epilepsy (NaME) Study prospectively recruited a new cohort of women with epilepsy and their offspring for longitudinal follow-up.

METHODS: Pregnant women of <21 weeks gestation (n=401) were recruited from 21 hospitals in the UK. Data collection occurred during pregnancy (recruitment, trimester 3) and at 12 and 24 months of age. The primary outcome was blinded assessment of infant cognitive, language and motor development on the Bayley Scales of Infant and Toddler Development (3 rd edition) at 24 months of age with supplementary parent reporting on the Vinelands Adaptive Behavior Scales (2 nd edition).

RESULTS: There were 394 live births with 277 children (70%) completing the Bayley assessment at 24 months. There was no evidence of an association of prenatal exposure to monotherapy with lamotrigine (-0.74, SE 2.9, 95% CI -6.5 to 5.0, p=.80) or levetiracetam (-1.57, SE 3.1, 95% CI -4.6 to 7.7 p=.62) with poorer infant cognition, following adjustment for other maternal and child factors in comparison to non-exposed children. Similar results were observed for language and motor scores. There was no evidence of an association between increasing doses of either lamotrigine or levetiracetam. Neither was there evidence that higher dose folic acid supplementation (=/> 5mg/d) or convulsive seizure exposure were associated with child development scores. Continued infant exposure to antiseizure medications through breastmilk was not associated with poorer outcomes, but the number of women breastfeeding beyond 3 months was low.

SIGNIFICANCE: These data are reassuring for infant development following in utero exposure to monotherapy lamotrigine or levetiracetam but child development is dynamic and future follow-up is required to rule out later emerging effects.

Original languageEnglish
Pages (from-to)2454-2471
Number of pages18
Issue number9
Early online date5 Jul 2023
Publication statusPublished - 19 Sept 2023


  • antiseizure medication
  • development
  • epilepsy
  • pharmacovigilance
  • pregnancy


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