Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AG01) valproic acid
valproic acid
(N03AF01) carbamazepine
carbamazepine
(N03AX09) lamotrigine
lamotrigine
(N03AX14) levetiracetam
levetiracetam
(N03AX15) zonisamide
zonisamide
(N03AX18) lacosamide
lacosamide
(N03AX11) topiramate
topiramate

Medical condition to be studied

Epilepsy
Foetal anticonvulsant syndrome
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

660
Study design details

Main study objective

The investigation into methods of routine surveillance for longer-term child health and neurodevelopmental outcomes in children exposed to medications in utero.

Outcomes

The feasibility of undertaking routine follow up for longer term outcomes. This will be measured by the ability to recruit and retain women during their pregnancy and past their child's 2nd birthday.

Data analysis plan

Data will be analyzed investigating the feasibility and the acceptability of the LIFETIME System. Frequency information will be provided with regards to number of women recruited in specific time periods by specific groups and as a total by medication type. Rates of completion of the Ages and Stages Questionnaires at each age point, stratified by key demographic variables will be calculated. Rates of questionnaire completion and missing data will also be calculated.