NCT06580834

Newborn Brain Test (NBT)

Newborn Brain Test (NBT): Assessment of Newborn Brain Function Using Automated AI Assessment, Phase1 Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Professor Geraldine Boylan · Academic / Other
• Sex: All
• Age: 37 Weeks – 45 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Seizures Newborn
• Brain Injuries

Interventions

Type	Name	Description
DEVICE	Cergenx Wave	Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-01-29
• Completion: 2025-02-04
• First posted: 2024-08-30
• Last updated: 2025-04-09

Locations

1 site across 1 country: Ireland