DARWIN EU® - Neonatal seizures: Incidence, prevalence, patient characterisation, and treatments in European countries

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Neonatal seizure

Population studied

• Short description of the study population:
  Descriptive epidemiology study (objective 1): The study population will include all neonates, defined as ; infants from birth to 28 days of life, present in the data source between 1 January 2014 and 31 December ; 2024 (or the latest date available). ; Characterisations (objectives 2, 3(i, ii) and 4: The study population will include all neonates with a first ; recorded diagnosis of seizures during the neonatal period, present in the data source between 1 January ; 2014 and 31 December 2024 (or the latest date available). For outcome analyses (objective 4), only ; neonates diagnosed with seizures at least 90 days prior to the end of data availability in each data source ; will be included to ensure sufficient follow-up. Additionally, for objective 4, eligible neonates must have no ; prior recorded diagnosis of the outcome condition of interest before the index date (date of seizure ; diagnosis). ; Drug utilisation study (objective 3(iii)): The study population will include neonates diagnosed with seizures ; who initiate anti-seizure pharmacological treatment during the neonatal period and who are present in the ; data source between 1 January 2014 and 31 December 2024 (or the latest date available). To ensure a new; user design, eligible neonates must have no prior record of anti-seizure medication use before the index ; date (date of treatment initiation).
• Age groups:
  • Neonate

    • Preterm newborn infants (0 – 27 days)
    • Term newborn infants (0 – 27 days)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 5 data sources from 5 countries ; across Europe and in 4 EU member states.
• Main study objective:
  1. To estimate the incidence and prevalence of seizures in neonates. ; 2. To characterise the demographic and clinical profile of neonates at the time of seizure diagnosis ; including: ; • Sex ; • Age ; • Gestational age ; • Birth weight ; • Clinical manifestations of seizures ; • Diagnostic tools used (e.g., EEG) and, where feasible, availability of EEG modalities (such as ; conventional EEG, amplitude EEG, or video EEG) ; • Comorbidities and concurrent conditions, including those presenting a high risk for seizure ; development, such as hypoxic-ischaemic encephalopathy, stroke or haemorrhage, infections, ; cortical malformations, errors of metabolism (acute and inborn), and genetic aetiologies ; • Comedication ; 3. To characterise i) treatment received from the primary diagnosis of seizures in neonates, ii) ; treatment patterns, and iii) duration of treatment. ; 4. To describe short-, mid-, and long-term outcomes among neonates diagnosed with seizures ; (including survival and related diagnosed conditions such as neurodevelopmental and neurological ; disorders) at 3 months, 6 months, 2 years, and 6–7 years of age.