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

NCT05079971 | Unknown

• 1 other identifier: A 096043
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Seizures

Keywords

Neonatal Seizures; cEEG; aEEG; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Each participant will be assessed in Group A (aEEG review only) or Group B (a+cEEG) for 24 hours.

Secondary Outcomes (4)

• Time from first recorded seizure to first recognised seizure and to treatment.

  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.

• Number of false positive seizure detections clinically and/or by aEEG

  Followed until their discharge from hospital, or for up to 6 months, whichever came first.

• Off-line seizure burden (min/hr) detected by aEEG vs detected by cEEG

  Followed until their discharge from hospital, or for up to 6 months, whichever came first.

• Parental and staff acceptance of EEG monitoring (combined cohort) using questionnaire.

  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.

Study Arms (2)

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

ACTIVE COMPARATOR

Diagnostic Test: Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology

Group B is undergoing aEEG monitoring with concurrent full EEG review

EXPERIMENTAL

Diagnostic Test: Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology

Interventions

Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 32 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Luton and Dunstable Hospital NHS Foundation Trust: collaborator
• Infant, University College Cork, Ireland: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 28118303 BACKGROUND

• 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.

  PMID: 19490044 BACKGROUND

• 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.

  PMID: 31324321 BACKGROUND

• 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.

  PMID: 31783981 BACKGROUND

• 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.

  PMID: 31992265 BACKGROUND

• 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.

  PMID: 26456517 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ronit M Pressler, Phd MD MRCPCH

CONTACT

07737333607; r.pressler@ucl.ac.uk

Topun Austin, MD MRCP MRCPCH PhD

CONTACT

01223217677; topun.austin@addenbrookes.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr (Clinical Neurophysiology)

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 15, 2021
• Study Start: July 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

GB (1)