SeizuresANSeRNCT02431780
A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection
A study testing ANSeR Software System in people with Seizures and Brain Diseases, run by University College Cork at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 36 to 44 weeks
- Conditions the study is for
- Seizures, Brain Diseases, Central Nervous System Diseases
- What is being tested?
- ANSeR Software System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 12 Feb 2015to 7 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- • No parental/guardian consent
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom4 sites
Barts and the London NHS Trust,
London, E1 1BB
The London and Homerton Hospital
London, E9 6SR.
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Great Ormond Street Hospital
London, WC1N3JH
Ireland2 sites
Rotunda Maternity Hospital
Dublin
Cork University Maternity Hospital
Wilton, Cork
Netherlands1 site
University Medical Centre Utrecht, Wilhelmina Children's Hospital
Utrecht, KE 04.123.1, Po Box 85090
Sweden1 site
Karolinska Institutet and University Hospital
Huddinge, Stockholm County, K78 141 86
About this study
Official title: A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition
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.
Read the 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.
- Conditions
- Seizures, Brain Diseases, Central Nervous System Diseases, Epilepsy, Nervous System Diseases, Neurologic Manifestations
- Being tested
- ANSeR Software System
- Keywords
- Neonatal Seizures, Decision Support Algorithm, EEG
- Medical subject headings
- Seizures, Brain Diseases, Central Nervous System Diseases, Epilepsy, Nervous System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANSeR Software SystemDevice
ANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool
| Study group | Role | What they receive |
|---|---|---|
| non ANSeR Software System | No intervention | Routine clinical EEG monitoring |
| ANSeR Software System | Experimental | 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 Receives: Device: ANSeR Software System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-18 months
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.
Measured: 12-18 months
Secondary outcomes (2)
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.
Measured: 12-18 months
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.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study start12 Feb 2015
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Wellcome Trust
- Responsible party
- Principal investigator, Professor Geraldine Boylan, University College Cork
- Investigators
- Janet Rennie, Doctor, Principal investigator, University College London HospitalsGeraldine Boylan, PhD, Principal investigator, University College Cork, Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431780
- Sponsor's protocol ID
- GB01/14UCC
- Acronym
- ANSeR
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32861271Pavel 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.
PubMed 36398397Pavel 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.
PubMed 36683815Pavel 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.
PubMed 34626667
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition
- ClinicalTrials.gov ID
- NCT02431780
- Acronym / sponsor ID
- ANSeR / GB01/14UCC
- Conditions
- Seizures, Brain Diseases, Central Nervous System Diseases, Epilepsy, Nervous System Diseases, Neurologic Manifestations
- Keywords
- Neonatal Seizures, Decision Support Algorithm, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University College, London, Wellcome Trust
- Study start
- 12 Feb 2015 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non ANSeR Software System | No intervention | –Routine clinical EEG monitoring |
| ANSeR Software System | Experimental | Device: ANSeR Software SystemThe 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 |
Who may qualify
- Ages
- 36 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates 36 weeks - 44 weeks corrected gestational age in whom EEG monitoring is indicated because they are deemed to be
Key exclusion criteria (1 listed)
- • No parental/guardian consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANSeR Software SystemANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool | Device | ANSeR Software System |
Primary outcome
The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.
Time frame: 12-18 months
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.
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.
Time frame: 12-18 months
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.
2 secondary outcomes
Seizure burden (min) for all Neonates enrolled in the investigation arm compared to Seizure burden (min) for all Neonates in the control arm.
Time frame: 12-18 months
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.
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Results publication: PubMed 32861271Pavel 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.
- Results publication: PubMed 36398397Pavel 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.
- Results publication: PubMed 36683815Pavel 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.
- Results publication: PubMed 34626667Pavel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Rennie, Doctor principal investigator
University College London Hospitals
Geraldine Boylan, PhD principal investigator
University College Cork, Cork, Ireland
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANSeR Software System in people with Seizures and Brain Diseases, run by University College Cork at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Ireland, Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12-18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431780, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.