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A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition
The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.
This will be an open, two arm, parallel group, randomised, controlled investigation of the ANSeR Software System as a stand-alone neonatal seizure recognition decision support tool. Term neonates requiring EEG monitoring will be stratified by recruiting site and then randomised to receive either EEG monitoring with the ANSeR Software System or EEG monitoring without the ANSeR Software System. It is proposed that the rate of true detections (sensitivity) of investigation personnel using the ANSeR Software System in clinical practice will be at least 25% higher than that of investigation personnel not using the ANSeR Software System in routine clinical practice. In addition we expect the specificity of investigation personnel using the ANSeR Software System to be no worse than 10% less than that of investigation personnel not using the ANSeR Software System. This should result in more appropriate and timely use of antiepileptic drugs (AED). Randomisation Immediately following enrolment in the investigation, each participant will be randomly assigned to receive either EEG monitoring with the ANSeR Software System or without the ANSeR Software System. Randomisation will be stratified by recruiting site with a 1:1 allocation ratio to each group. Block randomisation with varying block sizes will be used and the randomisation and allocation will be performed centrally using a web-based electronic system. Blinding As this is an investigation of a medical device (software), the investigation personnel will be aware of which group the participant is assigned to. The expert panel who are the diagnostic reference standard will be blinded to group allocation. The biostatistician will also be blinded to group allocation during the analysis of the data.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
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
Barts and the London NHS Trust,
London, United Kingdom
The London and Homerton Hospital
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Start Date
February 12, 2015
Primary Completion Date
February 7, 2017
Completion Date
February 7, 2017
Last Updated
December 11, 2023
264
ACTUAL participants
ANSeR Software System
DEVICE
Lead Sponsor
University College Cork
Collaborators
NCT05077904
NCT05667142
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05508789