Comparing EEG methods to diagnose neonatal seizures
The EAGLET Project: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy - a Randomised Trial
This study is testing whether a continuous EEG can help doctors find seizures in at-risk newborns faster and more accurately than a different type of EEG.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 32 Weeks and up |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT05079971 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effectiveness of continuous electroencephalography (cEEG) compared to amplitude-integrated electroencephalography (aEEG) in diagnosing neonatal seizures in at-risk infants. The study involves a multicentre randomized controlled trial where newborns will undergo 24 hours of EEG monitoring to assess seizure detection capabilities. The goal is to determine if cEEG can reduce the time to treatment and improve clinical outcomes for infants experiencing seizures. The study addresses the challenges of diagnosing neonatal seizures, which often have subtle clinical manifestations.
Who should consider this trial
Good fit: Ideal candidates include term or preterm neonates up to 28 days old who are at high risk for seizures due to various medical conditions.
Not a fit: Patients who do not have parental consent or have a poor prognosis for immediate survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis and treatment of neonatal seizures, improving outcomes for affected infants.
How similar studies have performed: Previous studies have shown varying success in comparing aEEG and cEEG, but this prospective approach aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cambridge
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Ronit M Pressler, Phd MD MRCPCH
- Email: r.pressler@ucl.ac.uk
- Phone: 07737333607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.