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

Epilepsy Clinical Trial

— ANSeR  

Official title:

A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431780
• Other study ID #: GB01/14UCC
• Status: Completed
• Phase: N/A
• Start date: February 12, 2015
• Est. completion date: February 7, 2017

Study information

• Verified date: December 2023
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

Description:

This will be an open, two arm, parallel group, randomised, controlled investigation of the ANSeR Software System as a stand-alone neonatal seizure recognition decision support tool. Term neonates requiring EEG monitoring will be stratified by recruiting site and then randomised to receive either EEG monitoring with the ANSeR Software System or EEG monitoring without the ANSeR Software System.

It is proposed that the rate of true detections (sensitivity) of investigation personnel using the ANSeR Software System in clinical practice will be at least 25% higher than that of investigation personnel not using the ANSeR Software System in routine clinical practice. In addition we expect the specificity of investigation personnel using the ANSeR Software System to be no worse than 10% less than that of investigation personnel not using the ANSeR Software System. This should result in more appropriate and timely use of antiepileptic drugs (AED).

Randomisation Immediately following enrolment in the investigation, each participant will be randomly assigned to receive either EEG monitoring with the ANSeR Software System or without the ANSeR Software System. Randomisation will be stratified by recruiting site with a 1:1 allocation ratio to each group. Block randomisation with varying block sizes will be used and the randomisation and allocation will be performed centrally using a web-based electronic system.

Blinding As this is an investigation of a medical device (software), the investigation personnel will be aware of which group the participant is assigned to. The expert panel who are the diagnostic reference standard will be blinded to group allocation. The biostatistician will also be blinded to group allocation during the analysis of the data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 44 Weeks

Eligibility

Inclusion Criteria:

• Neonates 36 weeks - 44 weeks corrected gestational age in whom EEG monitoring is indicated because they are deemed to be

• at high risk of seizures or

• are experiencing seizures

Exclusion Criteria:

• • No parental/guardian consent

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Epilepsy
• Nervous System Diseases
• Neurologic Manifestations
• Seizures

Intervention

Device:
• ANSeR Software System
ANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool

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	Barts and the London NHS Trust,	London
United Kingdom	Great Ormond Street Hospital	London
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, 

References & Publications (4)

Pavel AM, Mathieson SR, Livingstone V, O'Toole JM, Pressler RM, de Vries LS, Rennie JM, Mitra S, Dempsey EM, Murray DM, Marnane WP, Boylan GB; ANSeR Consortium. Heart rate variability analysis for the prediction of EEG grade in infants with hypoxic ischae — View Citation

Pavel AM, O'Toole JM, Proietti J, Livingstone V, Mitra S, Marnane WP, Finder M, Dempsey EM, Murray DM, Boylan GB; ANSeR Consortium. Machine learning for the early prediction of infants with electrographic seizures in neonatal hypoxic-ischemic encephalopat — View Citation

Pavel AM, Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Pressler RM, Kapellou O, Dempsey EM, Mathieson SR, Pavlidis E, van Huffelen AC, Livingstone V, Toet MC, Weeke LC, Finder M, Mitra S, Murray DM, Marnane WP, Boylan GB. A machine-learning algori — View Citation

Pavel AM, Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Pressler RM, Kapellou O, Dempsey EM, Mathieson SR, Pavlidis E, Weeke LC, Livingstone V, Murray DM, Marnane WP, Boylan GB. Neonatal Seizure Management: Is the Timing of Treatment Critical? J Pe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.	The rate of true seizure detection (sensitivity), as recorded on a Seizure Record form, 25% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.	12-18 months
Primary	The False Detections per hour (sensitivity) for all Neonates enrolled in the investigation arm compared to the False Detection Rate for all Neonates in the control arm.	The False Detections per hour (specificity), as recorded on a Seizure Record form, 10% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.	12-18 months
Secondary	Seizure burden (min) for all Neonates enrolled in the investigation arm compared to Seizure burden (min) for all Neonates in the control arm.	To quantify seizure burden (min) in the investigation arm and control arm.	12-18 months
Secondary	Number of Neonates administered Anti-epileptic drug (AED) in the investigation arm compared to Number of Neonates administered Anti-epileptic drug (AED) in the control arm.		12-18 months

External Links

•   ANSeR Study Research Group