An Observational Study of the NeuroBell EEG Monitor

NCT07508670 | Completed FDA Device

• 1 other identifier: MOS01/2023
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Observational; Neonatal seizure; medical device

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end off EEG analysis

Study Arms (1)

Full-term neonates

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.

Device: NeuroBell EEG Monitor

Interventions

NeuroBell EEG Monitor DEVICE

EEG Monitor

Full-term neonates

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates (male or female) admitted to the NICU of Cork University Maternity Hospital (CUMH) will be enrolled. The investigational device does not require any additional electrodes to be placed on the participants and does not cause interruption to standard practice.

You may qualify if:

• 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

You may not qualify if:

• No parental/guardian consent.

Sponsors & Collaborators

• University College Cork: lead
• NeuroBell Ltd: collaborator

Study Sites (1)

University College Cork

Cork, T12 YE02, Ireland

Location

MeSH Terms

Conditions

Seizures; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory

Study Officials

• Brian Walsh, MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: September 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 3, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)