EAGLET: EEG vs aEEG in diagnosing neonatal seizures & epilepsy
Research type
Research Study
Full title
EAGLET: EEG vs aEEG to improve the diagnosis of neonataL seizures and Epilepsy – a randomised Trial
IRAS ID
302295
Contact name
Ronit Pressler
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
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 injury, about 10-15% represent genetic forms of epilepsy which are often diagnosed late, thus limiting the timely use of targeted therapies. Lack or delayed start of treatment results in a high seizure burden which is independently associated with worse clinical outcomes (Pinchefsky & Hahn 2017).
Diagnosing neonatal seizures is challenging because most have only subtle or no clinical manifestation (Malone et al 2008). The gold standard for seizure detection is continuous electroencephalography (cEEG) (Pellegrine et al 2019). cEEG can assist with establish the aetiology of seizures, and their management (Boylan et al 2019). However, this capability is lacking in most neonatal intensive care units (NICU) due to lack of on-site specialist support (Gossling et al 2020). 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 (Rakshasbhuvankar et al 2015). 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) (Rakshasbhuvankar et al 2015).
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.REC name
London - Central Research Ethics Committee
REC reference
21/LO/0870
Date of REC Opinion
30 Nov 2021
REC opinion
Unfavourable Opinion