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

University College Cork (UCC)

Status: Completed

Conditions: Seizures; Neurologic Manifestations; Epilepsy; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases

Treatments: Device: ANSeR Software System

Study type: Interventional

Funder types: Other

Identifiers

NCT02431780

GB01/14UCC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 36 to 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

non ANSeR Software System

No Intervention group

Description:

Routine clinical EEG monitoring

ANSeR Software System

Experimental group

Description:

The intended use of the ANSeR Software System is to provide a real time decision support tool to assist in the diagnosis of seizures in neonates (between 36 weeks and 44 weeks corrected age) and to provide a review tool for EEG and seizure analysis. ANSeR is intended to provide a reliable, effective, objective and intuitive means of identifying seizures

Treatment:

Device: ANSeR Software System