convulsions fits
Conditions
Interventions
EEG monitoring with the ANSeR Software System as a seizure detection algorithm.
Sponsors
University College Cork, National University of Ireland
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Neonates 36-44 weeks corrected gestational age in whom EEG monitoring is indicated because they are deemed to be; - at high risk of seizures, or - are experiencing seizures
Exclusion criteria
Exclusion criteria: No parental/guardian consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of investigation personnel with and without the use of the ANSeR Software System in routine clinical practice for a minimum of 2 hours up to maximum of 100 hours of post-natal EEG monitoring, using an expert panel as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be used to determine the impact of the ANSeR Software System. (1) The number and duration of all electrographic seizures will be quantified to measure seizure burden in both groups. Electrographic seizures will be determined by the expert EEG committee. (2) The number of AEDs administered in both groups will be compared. The timing of administration will be correlated with on-going electrographic seizure activity in each group to determine the appropriateness of AED administration | — |
Countries
Netherlands
Outcome results
None listed