An Observational Study of the NeuroBell EEG Monitor

University College Cork (UCC)

Status: Completed

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

Treatments: Device: NeuroBell EEG Monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07508670

MOS01/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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.

Trial design

17 participants in 1 patient group

Full-term neonates

Description:

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.

Treatment:

Device: NeuroBell EEG Monitor