Skip to content

Electroencephalography in the Neonate: Seizure Detection

Electroencephalography in the Neonate: Seizure Detection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000639628
Acronym
ELITE
Enrollment
4
Registered
2023-06-14
Start date
2024-09-10
Completion date
2025-11-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Continuous Electroencephalography (cEEG) monitoring in neonates provides information on evolving neurological conditions in neonates in the neonatal intensive care unit (NICU). The aim of this study is to clinically validate an automated seizure detection algorithm by comparing EEG interpretations with the gold standard reading by a Paediatric Neurologist. A second aim of the study is to validate the algorithm when housed within a custom built wireless EEG machine and compare that to a commercially available cEEG machine

Interventions

There are 2 interventions being tested: 1. Seizure detection algorithm software installed into a commercial grade EEG machine 2. Seizure detection algorithm software installed into a custom-built wireless EEG machine Babies born >35 weeks who are admitted to the intensive care nursery for seizures or who are at-risk of seizures will be eligible to participate. Once consent is obtained, all neonatal participants will undergo a 9 channel EEG using standard scalp electrodes. Electrodes will be

There are 2 interventions being tested: 1. Seizure detection algorithm software installed into a commercial grade EEG machine 2. Seizure detection algorithm software installed into a custom-built wireless EEG machine Babies born >35 weeks who are admitted to the intensive care nursery for seizures or who are at-risk of seizures will be eligible to participate. Once consent is obtained, all neonatal participants will undergo a 9 channel EEG using standard scalp electrodes. Electrodes will be placed on the scalp and checked by a neuroscientist who usually performs neonatal clinical EEG requests. The waveform will not be visible to clinicians and the data collected will be analysed offline by Paediatric Neurologists. The commercial grade EEG machine will be placed onto the baby, after 4 hours of recording, the electrodes will be disconnected from this machine and the wireless EEG machine will be connected using the same scalp electrodes for another 4 hour recording. The first intervention will test the seizure detection algorithm software and determine its accuracy against the gold standard reading by a Paediatric Neurologist. The second intervention will test the algorithm installed in a custom-built wireless EEG machine. Accuracy will be determined by comparing its recording with the commercial grade EEG machine. Compared to the commercial EEG machine, the wireless EEG machine is much more compact in size (size of a credit card), is battery operated and small enough to fit inside the baby's cot. All recordings will be supervised by a neuroscientist or neonatal nurse. The overall duration of recording will be up to a total of 8 hours, depending on cares, feeds, other investigations etc. Apart from switching electrodes between machines, no specific training is required for the neuroscientist. Any training of neonatal staff will be brief and take place prior to the baby being placed on EEG.

Sponsors

Queensland Institute of Medical Research (QIMR) Berghofer
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Weeks to 44 Weeks
Healthy volunteers
No

Inclusion criteria

Infants eligible for inclusion are infants born > 35 weeks gestational age and are at risk of seizures, these include infants who have had a seizure, with hypoxic ischaemic encephalopathy (HIE), or have had abnormal movements, with a clinical concern for seizures.

Exclusion criteria

Exclusion criteria will be if the neonatal electrodes are unable to be placed adequately for a recording (e.g. other interfering equipment) or if the prognosis is extremely poor and redirection to palliative care is imminent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026