ANSeR- The Algorithm for Neonatal Seizure Recognition Study

Completed

• Conditions: Neonatal Seizures
• Interventions: Device: Algorithm for Neonatal Seizure Recognition

• Registration Number: NCT02160171
• Lead Sponsor: University College Cork

Brief Summary

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term neonates	Algorithm for Neonatal Seizure Recognition	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'

Primary Outcome Measures

Name	Time	Method
To quantify the overall diagnostic accuracy of the Algorithm.	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

Name	Time	Method
Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)	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.	up to 72 hours	To examine factors that influence diagnostic accuracy in clinical practice.

Trial Locations

Locations (6)

Rotunda Maternity Hospital; 🇮🇪 Dublin, Ireland

University Medical Centre Utrecht, Wilhelmina Children's Hospital; 🇳🇱 Utrecht, Netherlands

Karolinska Institutet and University Hospital; 🇸🇪 Huddinge, Stockholm, Sweden

The London and Homerton Hospital; 🇬🇧 London, United Kingdom

Cork University Maternity Hospital; 🇮🇪 Wilton, Cork, Ireland

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom