ANSeR- The Algorithm for Neonatal Seizure Recognition Study

Neonatal Seizures Clinical Trial

— ANSeR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160171
• Other study ID #: GB0113UCC
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: August 10, 2015
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Weeks and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Seizures
• Seizures

Intervention

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

Locations

Country	Name	City	State
Ireland	Rotunda Maternity Hospital	Dublin
Ireland	Cork University Maternity Hospital	Wilton	Cork
Netherlands	University Medical Centre Utrecht, Wilhelmina Children's Hospital	Utrecht
Sweden	Karolinska Institutet and University Hospital	Huddinge	Stockholm
United Kingdom	The London and Homerton Hospital	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
University College Cork	University College, London, Wellcome Trust

Countries where clinical trial is conducted

Ireland,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)	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).	up to 72 hours	No
Secondary	To examine factors that influence diagnostic accuracy in clinical practice.	To examine factors that influence diagnostic accuracy in clinical practice.	up to 72 hours	No

External Links

•   ANSeR study website