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The aim of the overall project is to develop the Newborn Brain Test (NBT), a novel platform to detect abnormal brain activity in infants at birth through an automated AI assessment. Easy to interpret results, provided in less than 15 minutes, will allow for immediate follow up by a medical team when abnormal brain function is detected.
NBT has been developed by INFANT's study partner CergenX (UCC Spinout company), who sponsors the study. INFANT is responsible for the clinical aspect of the project and will conduct a feasibility study of the device as well as a larger pivotal investigation.
EEG activity will be recorded using the standard CE marked portable EEG amplifier with four electrodes on the scalp. The test will be controlled using a tablet. The captured waveforms will be sent to the cloud where the NBT Artificial Intelligence (AI) algorithm analyses EEG activity, analyses the data and decides whether the test was or was not completed successfully. The test takes approximately 15 minutes to complete. The device has been trained with EEG data from full term infants. It is not a diagnostic test, simply a screener.
The EEG and anonymised patient data collected during the NBT test will be processed and stored in the NBT secure AWS infrastructure. During the feasibility study, the result (EEG reading or result of AI algorithm) from the device will not be available to the research team so as not to influence clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal Intensive care Unit | 50% of the babies recruited will be from the Neonatal Intensive Care Unit. All term neonates ≥ 37 and ≤ 45 weeks corrected gestation age are eligible for the NBT study that do not have head trauma or broken skin on the scalp. |
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| Post Natal Ward | 50% of the babies recruited will be from the Post Natal Ward. All term neonates ≥ 37 and ≤ 45 weeks corrected gestation age are eligible for the NBT study that do not have head trauma or broken skin on the scalp. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cergenx Wave | Device | Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings | Feasibility of the device is achieved if a good quality recording on the first attempt is achieved in at least 80% of infants , i.e. the device is not feasible if the success rate is <80%. Acceptable EEG in terms of technical quality for satisfactory review:
A 'majority' (50%+) of the EEG should be artefact free and readable. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt |
|
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Inclusion Criteria:
Exclusion Criteria:
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90 babies will be recruited in total that meet the inclusion criteria above. 45 will be from the Neonatal Intensive care Unit and 45 from the Post natal Ward
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| Name | Affiliation | Role |
|---|---|---|
| Geraldine Boylan, Professor | University College Cork INFANT Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Maternity Hospital | Cork | T12 YE02 | Ireland |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Day 1 |
| Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt. |
| Day 1 |
| Number of attempts by a user before a good quality recording is achieved (Max 3 attempts) | A count of the failed attempts to make a recording. A failed recording is where no results are obtained from the tablet | Day 1 |
| Assessment of healthcare satisfaction with useability of the device and procedure derived from data captured during recordings and interviews. | Information on healthcare professional satisfaction with the device will be collected by means of completed System Useability Scale (SUS) Questionnaires. Interviews will also be conducted with the healthcare professionals using pre-defined questions to gain further knowledge and information on the use of the device. | The interviews will be conducted with the researchers after 10 weeks, after 20 weeks and at the end of the study - up to 30 weeks |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |