Newborn Brain Test (NBT)
NCT Number: NCT06580834
Acronym: NBT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Seizures Newborn|Brain Injuries
Sponsor: Professor Geraldine Boylan
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-22
Completion Date: 2025-04-30

Summary:
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.

Primary Outcome Measures: 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:

* The recording should clearly be recording brain activity; if an electrode is poorly attached or detached, the EEG channel is likely to show continuous high amplitude/chaotic artifact which is not acceptable.
* The brain activity for a term baby should contain continuous activity of mixed frequency content (delta, theta, alpha activity) with amplitudes ranging from 25-150µV.
* The EEG should not be marred by persistent 50Hz due to high electrode impedance, that makes the recording unreadable.

A 'majority' (50%+) of the EEG should be artefact free and readable., Day 1
Secondary Outcome Measures: Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt, * A - Time taken to set up the device and put on the electrodes;
* B - Time taken from electrode application to starting the device;
* C - Time from pressing start on the device to results obtained;
* D - Time from results obtained to removal of electrodes
* Total time as above (A+B+C+D), Day 1|Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt., * A - Time taken to set up the device and put on the electrodes;
* B - Time taken from electrode application to starting the device;
* C - Time from pressing start on the device to results obtained;
* D - Time from results obtained to removal of electrodes
* Total time as above (A+B+C+D), 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