Clinical trial NCT06580834: Newborn Brain Test (NBT)
Official title: Newborn Brain Test (NBT): Assessment of Newborn Brain Function Using Automated AI Assessment, Phase1 Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures Newborn
Brain Injuries
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 93
Sex: ALL
Minimum age (years): 37
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All neonates≥ 37 and ≤45 weeks gestational age
* Parental informed consent

Exclusion Criteria:

* Any Infant with head trauma or broken skin on the scalp
* Informed consent not obtained.

Primary outcomes:
measure: Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings
timeFrame: Day 1
Secondary outcomes:
measure: Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt
timeFrame: Day 1
measure: Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt.
timeFrame: Day 1
measure: Number of attempts by a user before a good quality recording is achieved (Max 3 attempts)
timeFrame: Day 1
measure: Assessment of healthcare satisfaction with useability of the device and procedure derived from data captured during recordings and interviews.
timeFrame: 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
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
affiliation: University College Cork INFANT Centre
name: Geraldine Boylan, Professor
role: STUDY_DIRECTOR
References: