None listed
Conditions
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 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
Study design
Eligibility
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.