NCT02431780

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 12, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

November 14, 2014

Last Update Submit

December 4, 2023

Conditions

SeizuresBrain DiseasesCentral Nervous System DiseasesEpilepsyNervous System DiseasesNeurologic Manifestations

Keywords

Neonatal SeizuresDecision Support AlgorithmEEG

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 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.

    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.

    12-18 months

Study Arms (2)

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

Device: ANSeR Software System

Interventions

ANSeR Software SystemDEVICE

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

ANSeR Software System

Eligibility Criteria

Age36 Weeks - 44 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No parental/guardian consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cork University Maternity Hospital

Wilton, Cork, Ireland

Location

Rotunda Maternity Hospital

Dublin, Ireland

Location

University Medical Centre Utrecht, Wilhelmina Children's Hospital

Utrecht, KE 04.123.1, Po Box 85090, Netherlands

Location

Karolinska Institutet and University Hospital

Huddinge, Stockholm County, K78 141 86, Sweden

Location

Barts and the London NHS Trust,

London, E1 1BB, United Kingdom

Location

The London and Homerton Hospital

London, E9 6SR., United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Great Ormond Street Hospital

London, WC1N3JH, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 32861271RESULT

  • 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.

    PMID: 36398397RESULT

  • 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.

    PMID: 36683815RESULT

  • 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.

    PMID: 34626667RESULT

Related Links

MeSH Terms

Conditions

SeizuresBrain DiseasesCentral Nervous System DiseasesEpilepsyNervous System DiseasesNeurologic Manifestations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janet Rennie, Doctor

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

  • Geraldine Boylan, PhD

    University College Cork, Cork, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2014

First Posted

May 1, 2015

Study Start

February 12, 2015

Primary Completion

February 7, 2017

Study Completion

February 7, 2017

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations

SE(1)NL(1)IE(2)GB(4)