A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection (ANSeR)

December 4, 2023 updated by: Professor Geraldine Boylan, University College Cork

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Rotunda Maternity Hospital
    • Cork
      • Wilton, Cork, Ireland
        • Cork University Maternity Hospital
  • Netherlands
      • Utrecht, Netherlands, KE 04.123.1, Po Box 85090
        • University Medical Centre Utrecht, Wilhelmina Children's Hospital
  • Sweden
    • Stockholm
      • Huddinge, Stockholm, Sweden, K78 141 86
        • Karolinska Institutet and University Hospital
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom, E9 6SR.
        • The London and Homerton Hospital
      • London, United Kingdom, WC1N3JH
        • Great Ormond Street Hospital
      • London, United Kingdom, E1 1BB
        • Barts and the London NHS Trust,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 10 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates 36 weeks - 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: non ANSeR Software System
Routine clinical EEG monitoring
Experimental: ANSeR Software System
The intended use of the ANSeR Software System is to provide a real time decision support tool to assist in the diagnosis of seizures in neonates (between 36 weeks and 44 weeks corrected age) and to provide a review tool for EEG and seizure analysis. ANSeR is intended to provide a reliable, effective, objective and intuitive means of identifying seizures
Device: ANSeR Software System
ANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.
Time Frame: 12-18 months
The rate of true seizure detection (sensitivity), as recorded on a Seizure Record form, 25% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.
12-18 months
The False Detections per hour (sensitivity) for all Neonates enrolled in the investigation arm compared to the False Detection Rate for all Neonates in the control arm.
Time Frame: 12-18 months
The False Detections per hour (specificity), as recorded on a Seizure Record form, 10% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.
12-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure burden (min) for all Neonates enrolled in the investigation arm compared to Seizure burden (min) for all Neonates in the control arm.
Time Frame: 12-18 months
To quantify seizure burden (min) in the investigation arm and control arm.
12-18 months
Number of Neonates administered Anti-epileptic drug (AED) in the investigation arm compared to Number of Neonates administered Anti-epileptic drug (AED) in the control arm.
Time Frame: 12-18 months
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

University College, London
Wellcome Trust

Investigators

  • Principal Investigator: Janet Rennie, Doctor, University College London Hospitals
  • Principal Investigator: Geraldine Boylan, PhD, University College Cork, Cork, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2015

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

February 7, 2017

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimated)

May 1, 2015

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB01/14UCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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