Clinical trial NCT02431780: A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection
Official title: A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Keywords: Neonatal Seizures
Decision Support Algorithm
EEG
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: University College, London
name: Wellcome Trust
First posted: 2015-05-01
Enrollment: 264
Sex: ALL
Minimum age (years): 36
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.
timeFrame: 12-18 months
measure: 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.
timeFrame: 12-18 months
Secondary outcomes:
measure: Seizure burden (min) for all Neonates enrolled in the investigation arm compared to Seizure burden (min) for all Neonates in the control arm.
timeFrame: 12-18 months
measure: 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.
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Wilton
country: Ireland
facility: Cork University Maternity Hospital
state: Cork
city: Dublin
country: Ireland
facility: Rotunda Maternity Hospital
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht, Wilhelmina Children's Hospital
city: Huddinge
country: Sweden
facility: Karolinska Institutet and University Hospital
state: Stockholm
city: London
country: United Kingdom
facility: Barts and the London NHS Trust,
city: London
country: United Kingdom
facility: The London and Homerton Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: University College London Hospitals
name: Janet Rennie, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Cork, Cork, Ireland
name: Geraldine Boylan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 algorithm for neonatal seizure recognition: a multicentre, randomised, controlled trial. Lancet Child Adolesc Health. 2020 Oct;4(10):740-749. doi: 10.1016/S2352-4642(20)30239-X. Epub 2020 Aug 27.
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 encephalopathy. Epilepsia. 2023 Feb;64(2):456-468. doi: 10.1111/epi.17468. Epub 2022 Dec 20.
citation: 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 ischaemic encephalopathy within the first 12 h of birth. Front Pediatr. 2023 Jan 4;10:1016211. doi: 10.3389/fped.2022.1016211. eCollection 2022.
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 Pediatr. 2022 Apr;243:61-68.e2. doi: 10.1016/j.jpeds.2021.09.058. Epub 2021 Oct 7.