NCT02160171

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

February 3, 2014

Last Update Submit

August 10, 2015

Conditions

Neonatal Seizures

Keywords

Decision Support AlgorithmNeonatal SeizuresEEG

Outcome Measures

Primary Outcomes (1)

  • To quantify the overall diagnostic accuracy of the Algorithm.

    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 Outcomes (2)

  • Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)

    up to 72 hours

  • To examine factors that influence diagnostic accuracy in clinical practice.

    up to 72 hours

Study Arms (1)

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

Interventions

Algorithm for Neonatal Seizure RecognitionDEVICE

Software system for neonatal seizure detection recognition

Also known as: ANSeR
Term neonates

Eligibility Criteria

Age36 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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.

You may not qualify if:

  • Consent of parents not obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cork University Maternity Hospital

Wilton, Cork, Ireland

Location

Rotunda Maternity Hospital

Dublin, Ireland

Location

University Medical Centre Utrecht, Wilhelmina Children's Hospital

Utrecht, KE 04.123.1, Po Box 85090, Netherlands

Location

Karolinska Institutet and University Hospital

Huddinge, Stockholm County, K78 141 86, Sweden

Location

The London and Homerton Hospital

London, E9 6SR., United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

  • Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Livingstone V, van Huffelen AC, Mathieson SR, Pavlidis E, Weeke LC, Toet MC, Finder M, Pinnamaneni RM, Murray DM, Ryan AC, Marnane WP, Boylan GB. Characterisation of neonatal seizures and their treatment using continuous EEG monitoring: a multicentre experience. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F493-F501. doi: 10.1136/archdischild-2018-315624. Epub 2018 Nov 24.

    PMID: 30472660DERIVED

Study Officials

  • Geraldine Boylan, Professor

    University College Cork

    PRINCIPAL INVESTIGATOR

  • Janet Rennie, Doctor

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neonatal Physiology

Study Record Dates

First Submitted

February 3, 2014

First Posted

June 10, 2014

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

NL(1)GB(2)IE(2)SE(1)