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ANSeR- The Algorithm for Neonatal Seizure Recognition Study (ANSeR)

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ClinicalTrials.gov Identifier: NCT02160171
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : August 11, 2015
Sponsor:
Collaborators:
University College, London
Wellcome Trust
Information provided by (Responsible Party):
Professor Geraldine Boylan, University College Cork

February 3, 2014
June 10, 2014
August 11, 2015
April 2013
June 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02160171 on ClinicalTrials.gov Archive Site
  • Inappropriate use/non-use of Anti Epileptic Drugs (AEDs) [ Time Frame: up to 72 hours ]
    To quantify the degree and duration of inappropriate use/non-use of AEDs with
    1. the off-line application of the ANSeR algorithm and
    2. routine clinical practice. To compare (a) and (b).
  • To examine factors that influence diagnostic accuracy in clinical practice. [ Time Frame: up to 72 hours ]
    To examine factors that influence diagnostic accuracy in clinical practice.
Same as current
Not Provided
Not Provided
 
ANSeR- The Algorithm for Neonatal Seizure Recognition Study
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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)
Neonatal Seizures
Device: Algorithm for Neonatal Seizure Recognition
Software system for neonatal seizure detection recognition
Other Name: ANSeR
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'
Intervention: Device: Algorithm for Neonatal Seizure Recognition
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. 2018 Nov 24. pii: fetalneonatal-2018-315624. doi: 10.1136/archdischild-2018-315624. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
408
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
36 Weeks and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   Netherlands,   Sweden,   United Kingdom
 
 
NCT02160171
GB0113UCC
No
Not Provided
Not Provided
Professor Geraldine Boylan, University College Cork
University College Cork
  • University College, London
  • Wellcome Trust
Principal Investigator: Geraldine Boylan, Professor University College Cork
Principal Investigator: Janet Rennie, Doctor University College, London
University College Cork
August 2015