Newborn Brain Test (NBT)

NCT ID: NCT06580834

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-02-04

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.

Conditions

Seizures Newborn; Brain Injuries

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cergenx Wave

Intervention Type: DEVICE

Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.

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.

Cergenx Wave

Intervention Type: DEVICE

Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.

Interventions

Cergenx Wave

Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 45 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Professor Geraldine Boylan

OTHER

Sponsor Role: lead

Responsible Party

Professor Geraldine Boylan

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Geraldine Boylan, Professor

Role: STUDY_DIRECTOR

University College Cork INFANT Centre

Locations

Cork University Maternity Hospital

Cork, , Ireland

Countries

Ireland

Other Identifiers

ECM 4 (tt) 05/12/2023

Identifier Type: -

Identifier Source: org_study_id