A multicentre, randomised, controlled, clinical Investigation of a standalone decision support Algorithm for Neonatal Seizure Recognitio
Completed
- Conditions
- convulsionsfits10039911
- Registration Number
- NL-OMON44340
- Lead Sponsor
- niversity College Cork, National University of Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
No parental/guardian consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Diagnostic accuracy of investigation personnel with and without the use of the<br /><br>ANSeR Software System in routine clinical practice for a minimum of 2 hours up<br /><br>to maximum of 100 hours of post-natal EEG monitoring, using an expert panel as<br /><br>the reference standard. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The following secondary endpoints will be used to determine the impact of the<br /><br>ANSeR Software System.<br /><br>(1) The number and duration of all electrographic seizures will be quantified<br /><br>to measure seizure burden in both groups. Electrographic seizures will be<br /><br>determined by the expert EEG committee.<br /><br>(2) The number of AEDs administered in both groups will be compared. The<br /><br>timing of administration will be correlated with on-going electrographic<br /><br>seizure activity in each group to determine the appropriateness of AED<br /><br>administration</p><br>