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

Neonatal Seizures Clinical Trial

Official title: The EAGLET Project: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy - a Randomised Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Epilepsy
• Neonatal Seizures
• Seizures

• NCT number: NCT05079971
• Study type: Interventional
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Ronit M Pressler, Phd MD MRCPCH
• Phone: 07737333607
• Email: r.pressler@ucl.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: December 2024