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| Name | Class |
|---|---|
| NeuroBell Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroBell EEG Monitor | Device | EEG Monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Walsh, MD | Cork University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Cork | Cork | T12 YE02 | Ireland |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |