EEG, Hypoxic Ischaemic Encephalopathy (HIE), Medical Devices, Neonatal Seizures, Neonatology, Neurology, Seizure
Conditions
Keywords
Observational, Neonatal seizure, medical device
Brief summary
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
Detailed description
The objective of the clinical investigation is to evaluate the signal quality of the NeuroBell EEG Monitor (hereinafter referred to as the investigational device) for use in acquiring neonatal EEG compared to a conventional EEG device.
Interventions
DEVICENeuroBell EEG Monitor
EEG Monitor
Sponsors
University College Cork
NeuroBell Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Full-term neonates (born between 36-44 weeks gestational age), in whom EEG monitoring is indicated as part of standard clinical care or as part of a separate study in which they are enrolled
Exclusion criteria
* Do not meet inclusion criteria * No parental/guardian consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of EEG signals from investigational device compared with standard of care EEG device | From enrollment to the end off EEG analysis | EEG signals recorded by the investigational device will be compared to the EEG signals recorded by the conventional EEG monitor. Confirmation that the investigational device records EEG signals are suitable for clinical interpretation. |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATORBrian Walsh, MD
Cork University Hospital
Outcome results
None listed