A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR
This is a multi-centre study. It will be based on routine clinical practice but will also allow for the off-line retrospective application of ANSeR to a well-defined clinical population in order to establish the potential diagnostic utility of the algorithm.
Study Type
OBSERVATIONAL
Enrollment
240
Software system for neonatal seizure detection recognition
Cork University Maternity Hospital
Wilton, Cork, Ireland
Rotunda Maternity Hospital
Dublin, Ireland
University Medical Centre Utrecht, Wilhelmina Children's Hospital
Utrecht, Netherlands
Karolinska Institutet and University Hospital
Huddinge, Stockholm County, Sweden
To quantify the overall diagnostic accuracy of the Algorithm.
To measure diagnostic accuracy of ANSeR (Algorithm) and clinicians (in routine clinical practice or optimised clinical practice) during the initial up to but not limited to 72 hour period of post-natal EEG monitoring, using an expert panel as the reference standard.
Time frame: up to 72 hours
Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)
To quantify the degree and duration of inappropriate use/non-use of AEDs with 1. the off-line application of the ANSeR algorithm and 2. routine clinical practice. To compare (a) and (b).
Time frame: up to 72 hours
To examine factors that influence diagnostic accuracy in clinical practice.
To examine factors that influence diagnostic accuracy in clinical practice.
Time frame: up to 72 hours
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The London and Homerton Hospital
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom