ANSeR- The Algorithm for Neonatal Seizure Recognition Study (ANSeR)
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|ClinicalTrials.gov Identifier: NCT02160171|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : August 11, 2015
|Condition or disease||Intervention/treatment|
|Neonatal Seizures||Device: Algorithm for Neonatal Seizure Recognition|
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Official Title:||A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Term neonates who are undergoing continuous video amplified Electroencephalogram (aEEG)/Electroencephalogram (EEG) monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia). EEGs will be analysed off line by 'Algorithm for Neonatal Seizure Recognition'
Device: Algorithm for Neonatal Seizure Recognition
Software system for neonatal seizure detection recognition
Other Name: ANSeR
- To quantify the overall diagnostic accuracy of the Algorithm. [ Time Frame: up to 72 hours ]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.
- Inappropriate use/non-use of Anti Epileptic Drugs (AEDs) [ Time Frame: up to 72 hours ]
To quantify the degree and duration of inappropriate use/non-use of AEDs with
- the off-line application of the ANSeR algorithm and
- routine clinical practice. To compare (a) and (b).
- To examine factors that influence diagnostic accuracy in clinical practice. [ Time Frame: up to 72 hours ]To examine factors that influence diagnostic accuracy in clinical practice.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160171
|Cork University Maternity Hospital|
|Wilton, Cork, Ireland|
|Rotunda Maternity Hospital|
|University Medical Centre Utrecht, Wilhelmina Children's Hospital|
|Utrecht, Netherlands, KE 04.123.1, Po Box 85090|
|Karolinska Institutet and University Hospital|
|Huddinge, Stockholm, Sweden, K78 141 86|
|The London and Homerton Hospital|
|London, United Kingdom, E9 6SR.|
|University College London Hospitals NHS Foundation Trust|
|London, United Kingdom, NW1 2BU|
|Principal Investigator:||Geraldine Boylan, Professor||University College Cork|
|Principal Investigator:||Janet Rennie, Doctor||University College, London|