An Observational Study of the NeuroBell EEG Monitor

University College Cork17 enrolled

Overview

An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

EEG Neonatology Seizure Neurology Hypoxic Ischaemic Encephalopathy (HIE)Neonatal Seizures Medical Devices

Interventions

NeuroBell EEG MonitorDEVICE

EEG Monitor

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

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.

Locations (1)

University College Cork

Cork, Ireland

Outcomes

Primary Outcomes

Evaluation of EEG signals from investigational device compared with standard of care EEG device

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.

Time frame: From enrollment to the end off EEG analysis

Data from ClinicalTrials.gov

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