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| Name | Class |
|---|---|
| University College, London | OTHER |
| Wellcome Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm for Neonatal Seizure Recognition | Device | Software system for neonatal seizure detection recognition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate use/non-use of Anti Epileptic Drugs (AEDs) | To quantify the degree and duration of inappropriate use/non-use of AEDs with
| up to 72 hours |
| To examine factors that influence diagnostic accuracy in clinical practice. |
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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.
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Geraldine Boylan, Professor | University College Cork | Principal Investigator |
| Janet Rennie, Doctor | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Maternity Hospital | Wilton | Cork | Ireland | |||
| Rotunda Maternity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30472660 | Derived | 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. |
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To examine factors that influence diagnostic accuracy in clinical practice. |
| up to 72 hours |
| Dublin |
| Ireland |
| University Medical Centre Utrecht, Wilhelmina Children's Hospital | Utrecht | KE 04.123.1, Po Box 85090 | Netherlands |
| Karolinska Institutet and University Hospital | Huddinge | Stockholm County | K78 141 86 | Sweden |
| The London and Homerton Hospital | London | E9 6SR. | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2BU | United Kingdom |