EAGLET: EEG vs CFM (aEEG) in diagnosing neonatal seizures & epilepsy
Research type
Research Study
Full title
EAGLET: EEG vs CFM (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).
Cerebral function monitoring (CFM, also referred to as amplitude-integrated electroencephalography, or aEEG) tracks a continuous trend of brain activity using only a limited number of electrodes. CFM is currently being used as the standard of care in the UK, however it is unclear (i) how many true seizures are missed, (ii) in how many neonates’ treatment is delayed due to lack of access to full continuous multichannel electroencephalography (referred to hereafter as full EEG for simplicity), and (iii) in how many cases CFM leads to incorrect (over/under) treatment. While both techniques have been used clinically in neonatal intensive care units (NICUs) for over 30 years with numerous studies comparing the diagnostic value of CFM and full EEG, no definitive advantage either method has been demonstrated so far. The diagnostic accuracy of CFM ranged widely between studies with sensitivities of 25-85% and specificities of 39-100%. This wide variability is due to poorly designed studies (retrospective, lack of adequate control group, inadequate or no power calculation) (Rakshasbhuvankar et al 2015).
The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full EEG is superior to CFM 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
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
22/EM/0033
Date of REC Opinion
30 Mar 2022
REC opinion
Further Information Favourable Opinion