Neurodevelopment of babies born to mothers with epilepsy: A prospective observational cohort study |
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| Authors: | 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 the NaME Study Group |
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| Institution: | 1. Division of Neuroscience, University of Manchester, Manchester, UK;2. Obstetric and Fetal Medicine, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester, UK;3. Department of Neurology, Belfast Health and Social Care Trust, Belfast, UK;4. Manchester Centre for Genomic Medicine, St. Mary's Hospital, University of Manchester, Manchester, UK;5. Department of Neuropsychology, Walton Centre for Neurology and Neurosurgery NHS Foundation Trust, Liverpool, UK;6. Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK;7. Department of Neurology, Walton Centre for Neurology and Neurosurgery NHS Foundation Trust, Liverpool, UK;8. School of Psychology, Deakin University, Burwood, Victoria, Australia;9. Department for Clinical Genetics, Nothern Genetics Service, Newcastle, UK;10. See Appendix 1 for all members of the NaME Study Group. |
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| Abstract: | Objective Despite widespread monotherapy use of lamotrigine or levetiracetam during pregnancy, prospectively collected, blinded child development data are still limited. The NaME (Neurodevelopment of Babies Born to Mothers With Epilepsy) 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 (3rd edition) at 24 months of age with supplementary parent reporting on the Vinelands Adaptive Behavior Scales (2nd 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 lamotrigine (−.74, SE = 2.9, 95% confidence interval 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 nonexposed 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. Nor was there evidence that higher dose folic acid supplementation (≥5 mg/day) or convulsive seizure exposure was associated with child development scores. Continued infant exposure to antiseizure medications through breast milk 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. |
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| Keywords: | antiseizure medication development epilepsy pharmacovigilance pregnancy |
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