ANSeR- The Algorithm for Neonatal Seizure Recognition Study

Overview

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

Full Title of Study: “A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

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.

Interventions

  • Device: Algorithm for Neonatal Seizure Recognition
    • Software system for neonatal seizure detection recognition

Arms, Groups and Cohorts

  • 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’

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 36 Weeks

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University College Cork
  • Collaborator
    • University College, London
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Geraldine Boylan, Professor of Neonatal Physiology – University College Cork
  • Overall Official(s)
    • Geraldine Boylan, Professor, Principal Investigator, University College Cork
    • Janet Rennie, Doctor, Principal Investigator, University College, London

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