ANSeR- The Algorithm for Neonatal Seizure Recognition Study

NCT ID: NCT02160171

Last Updated: 2015-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Detailed Description

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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

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Neonatal Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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'

Algorithm for Neonatal Seizure Recognition

Intervention Type DEVICE

Software system for neonatal seizure detection recognition

Interventions

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Algorithm for Neonatal Seizure Recognition

Software system for neonatal seizure detection recognition

Intervention Type DEVICE

Other Intervention Names

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ANSeR

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Consent of parents not obtained.
Minimum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Professor Geraldine Boylan

Professor of Neonatal Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geraldine Boylan, Professor

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Janet Rennie, Doctor

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Cork University Maternity Hospital

Wilton, Cork, Ireland

Site Status

Rotunda Maternity Hospital

Dublin, , Ireland

Site Status

University Medical Centre Utrecht, Wilhelmina Children's Hospital

Utrecht, , Netherlands

Site Status

Karolinska Institutet and University Hospital

Huddinge, Stockholm County, Sweden

Site Status

The London and Homerton Hospital

London, , United Kingdom

Site Status

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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Ireland Netherlands Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 30472660 (View on PubMed)

Other Identifiers

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GB0113UCC

Identifier Type: -

Identifier Source: org_study_id

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