ANSeR- The Algorithm for Neonatal Seizure Recognition Study (ANSeR)

August 10, 2015 updated by: Professor Geraldine Boylan, University College Cork

A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection

A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

240

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

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Term neonates who are undergoing continuous video aEEG/EEG monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia)

Description

Inclusion Criteria:

All term neonates at risk of seizures are eligible for the ANSeR study.

Neonates ≥ 36 weeks gestation will be recruited if:

They have a need for EEG monitoring.

Exclusion Criteria:

Consent of parents not obtained.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Term neonates
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 Names:
  • ANSeR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. the off-line application of the ANSeR algorithm and
  2. routine clinical practice. To compare (a) and (b).
up to 72 hours
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.
up to 72 hours

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: Geraldine Boylan, Professor, University College Cork
  • Principal Investigator: Janet Rennie, Doctor, University College, London

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

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

April 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB0113UCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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