Neonatal SeizuresANSeRNCT02160171
ANSeR- The Algorithm for Neonatal Seizure Recognition Study
An observational study of Neonatal Seizures, run by University College Cork at 6 sites in 4 countries.
Trial summary
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR Read more about this study
- Who is it for?
- Ages 36 weeks and older
- Conditions the study is for
- Neonatal Seizures
- What is being tested?
- Algorithm for Neonatal Seizure Recognition
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Apr 2013to Jun 2015
- Phase
- Observational
- 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 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Term neonates who are undergoing continuous video aEEG/EEG monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia)
Who may be able to join
- 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.
Who cannot join
- Consent of parents not obtained.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Ireland2 sites
Rotunda Maternity Hospital
Dublin
Cork University Maternity Hospital
Wilton, Cork
United Kingdom2 sites
The London and Homerton Hospital
London, E9 6SR.
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
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 Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR
Read the detailed 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.
- Conditions
- Neonatal Seizures
- Being tested
- Algorithm for Neonatal Seizure Recognition
- Keywords
- Decision Support Algorithm, Neonatal Seizures, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm for Neonatal Seizure RecognitionDevice
Also called ANSeR
Software system for neonatal seizure detection recognition
| Study group | Role | What they receive |
|---|---|---|
| Term neonates | Term neonates who are undergoing continuous video amplified Electroencephalogram (aEEG)/Electroencephalogram (EEG) monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia). EEGs will be analysed off line by 'Algorithm for Neonatal Seizure Recognition' Receives: Device: Algorithm for Neonatal Seizure Recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 72 hours
Secondary outcomes (2)
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).
Measured: up to 72 hours
To examine factors that influence diagnostic accuracy in clinical practice.
To examine factors that influence diagnostic accuracy in clinical practice.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 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
- Geraldine Boylan, Professor, Principal investigator, University College CorkJanet Rennie, Doctor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160171
- Sponsor's protocol ID
- GB0113UCC
- Acronym
- ANSeR
- Status last verified
- Aug 2015
- First submitted
- 3 Feb 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Livingstone V, van Huffelen AC, Mathieson SR, Pavlidis E, Weeke LC, Toet MC, Finder M, Pinnamaneni RM, Murray DM, Ryan AC, Marnane WP, Boylan GB. Characterisation of neonatal seizures and their treatment using continuous EEG monitoring: a multicentre experience. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F493-F501. doi: 10.1136/archdischild-2018-315624. Epub 2018 Nov 24.
PubMed 30472660
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection
- ClinicalTrials.gov ID
- NCT02160171
- Acronym / sponsor ID
- ANSeR / GB0113UCC
- Conditions
- Neonatal Seizures
- Keywords
- Decision Support Algorithm, Neonatal Seizures, EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University College, London, Wellcome Trust
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jun 2014 (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.
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term neonates | – | Device: Algorithm for Neonatal Seizure RecognitionTerm neonates who are undergoing continuous video amplified Electroencephalogram (aEEG)/Electroencephalogram (EEG) monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia). EEGs will be analysed off line by 'Algorithm for Neonatal Seizure Recognition' |
Who may qualify
- Ages
- 36 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Term neonates who are undergoing continuous video aEEG/EEG monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia)
Key inclusion criteria (3 listed)
- All term neonates at risk of seizures are eligible for the ANSeR study.
- They have a need for EEG monitoring.
Key exclusion criteria (1 listed)
- Consent of parents not obtained.
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 |
|---|---|---|
| Algorithm for Neonatal Seizure RecognitionAlso: ANSeRSoftware system for neonatal seizure detection recognition | Device | Term neonates |
Primary outcome
To quantify the overall diagnostic accuracy of the Algorithm.
Time frame: up to 72 hours
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.
2 secondary outcomes
Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)
Time frame: up to 72 hours
To examine factors that influence diagnostic accuracy in clinical practice.
Time frame: up to 72 hours
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 Aug 2015.
- Derived from this study: PubMed 30472660Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Livingstone V, van Huffelen AC, Mathieson SR, Pavlidis E, Weeke LC, Toet MC, Finder M, Pinnamaneni RM, Murray DM, Ryan AC, Marnane WP, Boylan GB. Characterisation of neonatal seizures and their treatment using continuous EEG monitoring: a multicentre experience. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F493-F501. doi: 10.1136/archdischild-2018-315624. Epub 2018 Nov 24.
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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.
Geraldine Boylan, Professor principal investigator
University College Cork
Janet Rennie, Doctor principal investigator
University College, London
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Seizures, run by University College Cork at 6 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ireland, United Kingdom, 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?
To quantify the overall diagnostic accuracy of the Algorithm. (time frame: up to 72 hours). 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 NCT02160171, which also lists 1 linked publication.
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 Aug 2015; AzTrials last refreshed its copy on 29 Oct 2026.