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EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy (EAGLET)

Primary Purpose

Neonatal Seizures

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Seizures focused on measuring Neonatal Seizures, cEEG, aEEG, Epilepsy

Eligibility Criteria

32 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Term or preterm neonate, born at post-menstrual age (PMA) 32-44 weeks;
  2. And at least one of the following:

    (2.1) Neonate with any clinical event suspicious of seizures (2.2) Neonate at high-risk of seizures with confirmed or suspected: (2.2.1) Hypoxic ischaemic encephalopathy (moderate to severe, or deemed eligible for therapeutic hypothermia) (2.2.2) Cerebral vascular insult (e.g., perinatal arterial ischaemic stroke, cerebral venous sinus thrombus) (2.2.3) Meningitis / encephalitis - Inflammatory (2.2.4) Inborn error of metabolism (2.2.5) Brain malformation (2.2.6) Large intraventricular haemorrhage (III-IV)

  3. Infant is up to 28 days of age
  4. Written informed parental consent can be obtained.

Exclusion Criteria:

  1. No parental consent
  2. Poor prognosis of immediate survival
  3. Any contraindication to perform EEG (e.g. structural pathologies interfering with EEG electrode placement, such as cephalohematoma or subgaleal haemorrhage).
  4. Infants born at less than 31+6 weeks PMA and infants who are or are suspected to be experiencing or are at high-risk of seizures when aged 29 days or older.

Sites / Locations

  • Cambridge University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A is a control group with aEEG monitoring only, and with retrospective cEEG review

Group B is undergoing aEEG monitoring with concurrent full EEG review

Arm Description

Outcomes

Primary Outcome Measures

Seizure detection yield of aEEG compared to full EEG
The primary outcome measure for the study is the difference in the number of correctly identified seizures by NICU staff in real time with (full EEG) or without (aEEG only) the support of clinical neurophysiology.

Secondary Outcome Measures

Time from first recorded seizure to first recognised seizure and to treatment.
Their time to treatment and time to discharge will also be noted.
Number of false positive seizure detections clinically and/or by aEEG
Off-line seizure burden (min/hr) detected by aEEG vs detected by cEEG
Parental and staff acceptance of EEG monitoring (combined cohort) using questionnaire.

Full Information

First Posted
September 13, 2021
Last Updated
August 9, 2023
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust, Luton and Dunstable Hospital NHS Foundation Trust, Infant, University College Cork, Ireland, Guy's and St Thomas' NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05079971
Brief Title
EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy
Acronym
EAGLET
Official Title
The EAGLET Project: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy - a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust, Luton and Dunstable Hospital NHS Foundation Trust, Infant, University College Cork, Ireland, Guy's and St Thomas' NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full or continuous electroencephalography (cEEG) is superior to amplitude-integrated electroencephalography (aEEG) in the real time evaluation and diagnosis of neonatal seizures and in reducing time to treatment. At-risk new-born infants will be recruited on the participating neonatal intensive care units (NICUs) by trained specialist staff and will have 24 hours of EEG monitoring.
Detailed Description
Seizures are the most common neurological emergency in the neonatal period, affecting over 2000 infants per year in the UK. Although neonatal seizures usually result from acute brain insults, about 10-15% represent genetic forms of epilepsy which are often diagnosed late, thus limiting the timely use of targeted therapies. Lack or delayed initiation of treatment results in a high seizure burden which is independently associated with worse clinical outcomes. Diagnosing neonatal seizures is challenging because most have only subtle or no clinical manifestation. The gold standard for seizure detection is continuous electroencephalography (cEEG). cEEG can assist with establish the aetiology of seizures, and their management. However, this capability is lacking in most neonatal intensive care units (NICU) due to lack of on-site specialist support. The more common amplitude-integrated EEG (aEEG) uses a limited number of electrodes and is easier to apply and interpret but has been shown to miss a significant number of seizures. It is unclear how often seizure treatment is missed or delayed due to lack of cEEG access. Although studies have compared the diagnostic value of aEEG and cEEG retrospectively, the measured sensitivity of aEEG ranges widely (25-85%), likely due to poor design (retrospective, lack of adequate control group, no power calculations). The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether cEEG is superior to aEEG in the real time evaluation and diagnosis of neonatal seizures and in reducing time to treatment. At-risk neonates will be recruited on the NICU by trained specialist staff and will have 24 hours of EEG monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Seizures
Keywords
Neonatal Seizures, cEEG, aEEG, Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A is a control group with aEEG monitoring only, and with retrospective cEEG review
Arm Type
Active Comparator
Arm Title
Group B is undergoing aEEG monitoring with concurrent full EEG review
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology
Intervention Description
In group B, the standart-care equivalent aEEG review is undertaken by NICU staff via a 2-channel display. In addition to the standard care, concurrent full EEG is reviewed remotely with regular feedback by a specialist trained clinical neurophysiologist. The clinical neurophysiology reports only on seizure burden, no information or direction is provided regarding clinical management.
Primary Outcome Measure Information:
Title
Seizure detection yield of aEEG compared to full EEG
Description
The primary outcome measure for the study is the difference in the number of correctly identified seizures by NICU staff in real time with (full EEG) or without (aEEG only) the support of clinical neurophysiology.
Time Frame
Each participant will be assessed in Group A (aEEG review only) or Group B (a+cEEG) for 24 hours.
Secondary Outcome Measure Information:
Title
Time from first recorded seizure to first recognised seizure and to treatment.
Description
Their time to treatment and time to discharge will also be noted.
Time Frame
Each participant's seizure burden, treatment and discharge timelines will be recorded up until their discharge from the hospital, or for up to 6 months, whichever came first.
Title
Number of false positive seizure detections clinically and/or by aEEG
Time Frame
Followed until their discharge from hospital, or for up to 6 months, whichever came first.
Title
Off-line seizure burden (min/hr) detected by aEEG vs detected by cEEG
Time Frame
Followed until their discharge from hospital, or for up to 6 months, whichever came first.
Title
Parental and staff acceptance of EEG monitoring (combined cohort) using questionnaire.
Time Frame
Parents may fill in the questionnaire online after their infant's discharge from hospital, the questionnaire will take a maximum of 10 minutes to complete.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Term or preterm neonate, born at post-menstrual age (PMA) 32-44 weeks; And at least one of the following: (2.1) Neonate with any clinical event suspicious of seizures (2.2) Neonate at high-risk of seizures with confirmed or suspected: (2.2.1) Hypoxic ischaemic encephalopathy (moderate to severe, or deemed eligible for therapeutic hypothermia) (2.2.2) Cerebral vascular insult (e.g., perinatal arterial ischaemic stroke, cerebral venous sinus thrombus) (2.2.3) Meningitis / encephalitis - Inflammatory (2.2.4) Inborn error of metabolism (2.2.5) Brain malformation (2.2.6) Large intraventricular haemorrhage (III-IV) Infant is up to 28 days of age Written informed parental consent can be obtained. Exclusion Criteria: No parental consent Poor prognosis of immediate survival Any contraindication to perform EEG (e.g. structural pathologies interfering with EEG electrode placement, such as cephalohematoma or subgaleal haemorrhage). Infants born at less than 31+6 weeks PMA and infants who are or are suspected to be experiencing or are at high-risk of seizures when aged 29 days or older.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronit M Pressler, Phd MD MRCPCH
Phone
07737333607
Ext
+44
Email
r.pressler@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Topun Austin, MD MRCP MRCPCH PhD
Phone
01223217677
Ext
+44
Email
topun.austin@addenbrookes.nhs.uk
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Topun Austin

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28118303
Citation
Pinchefsky EF, Hahn CD. Outcomes following electrographic seizures and electrographic status epilepticus in the pediatric and neonatal ICUs. Curr Opin Neurol. 2017 Apr;30(2):156-164. doi: 10.1097/WCO.0000000000000425.
Results Reference
background
PubMed Identifier
19490044
Citation
Malone A, Ryan CA, Fitzgerald A, Burgoyne L, Connolly S, Boylan GB. Interobserver agreement in neonatal seizure identification. Epilepsia. 2009 Sep;50(9):2097-101. doi: 10.1111/j.1528-1167.2009.02132.x. Epub 2009 Jun 1.
Results Reference
background
PubMed Identifier
31324321
Citation
Boylan GB, Kharoshankaya L, Mathieson SR. Diagnosis of seizures and encephalopathy using conventional EEG and amplitude integrated EEG. Handb Clin Neurol. 2019;162:363-400. doi: 10.1016/B978-0-444-64029-1.00018-7.
Results Reference
background
PubMed Identifier
31783981
Citation
Pellegrin S, Munoz FM, Padula M, Heath PT, Meller L, Top K, Wilmshurst J, Wiznitzer M, Das MK, Hahn CD, Kucuku M, Oleske J, Vinayan KP, Yozawitz E, Aneja S, Bhat N, Boylan G, Sesay S, Shrestha A, Soul JS, Tagbo B, Joshi J, Soe A, Maltezou HC, Gidudu J, Kochhar S, Pressler RM; Brighton Collaboration Neonatal Seizures Working Group. Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7596-7609. doi: 10.1016/j.vaccine.2019.05.031. No abstract available.
Results Reference
background
PubMed Identifier
31992265
Citation
Gossling L, Alix JJP, Stavroulakis T, Hart AR. Investigating and managing neonatal seizures in the UK: an explanatory sequential mixed methods approach. BMC Pediatr. 2020 Jan 28;20(1):36. doi: 10.1186/s12887-020-1918-4.
Results Reference
background
PubMed Identifier
26456517
Citation
Rakshasbhuvankar A, Paul S, Nagarajan L, Ghosh S, Rao S. Amplitude-integrated EEG for detection of neonatal seizures: a systematic review. Seizure. 2015 Dec;33:90-8. doi: 10.1016/j.seizure.2015.09.014. Epub 2015 Sep 26.
Results Reference
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EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy

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