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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02160171
First Posted: June 10, 2014
Last Update Posted: August 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University College, London
Wellcome Trust
Information provided by (Responsible Party):
Professor Geraldine Boylan, University College Cork
  Purpose
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Condition Intervention
Neonatal Seizures Device: Algorithm for Neonatal Seizure Recognition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection

Resource links provided by NLM:


Further study details as provided by Professor Geraldine Boylan, University College Cork:

Primary Outcome 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 Outcome 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

    1. the off-line application of the ANSeR algorithm and
    2. 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.


Enrollment: 240
Study Start Date: April 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: ANSeR

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Ireland
Cork University Maternity Hospital
Wilton, Cork, Ireland
Rotunda Maternity Hospital
Dublin, Ireland
Netherlands
University Medical Centre Utrecht, Wilhelmina Children's Hospital
Utrecht, Netherlands, KE 04.123.1, Po Box 85090
Sweden
Karolinska Institutet and University Hospital
Huddinge, Stockholm, Sweden, K78 141 86
United Kingdom
The London and Homerton Hospital
London, United Kingdom, E9 6SR.
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College Cork
University College, London
Wellcome Trust
Investigators
Principal Investigator: Geraldine Boylan, Professor University College Cork
Principal Investigator: Janet Rennie, Doctor University College, London
  More Information

Additional Information:
Responsible Party: Professor Geraldine Boylan, Professor of Neonatal Physiology, University College Cork
ClinicalTrials.gov Identifier: NCT02160171     History of Changes
Other Study ID Numbers: GB0113UCC
First Submitted: February 3, 2014
First Posted: June 10, 2014
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Professor Geraldine Boylan, University College Cork:
Decision Support Algorithm
Neonatal Seizures
EEG

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms