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Completed

NCT Number: NCT06580834

Newborn Brain Test (NBT)

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.

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Key information

Conditions

Seizures Newborn Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

37 week–45 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital

Cork, T12 YE02, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cergenx Wave

Device

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

Primary outcomes

  1. Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings

    Time frame: Day 1

    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.

Secondary outcomes

  1. Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt

    Time frame: Day 1

    • 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)

  2. Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt.

    Time frame: Day 1

    • 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)

  3. Number of attempts by a user before a good quality recording is achieved (Max 3 attempts)

    Time frame: Day 1

    A count of the failed attempts to make a recording. A failed recording is where no results are obtained from the tablet

  4. Assessment of healthcare satisfaction with useability of the device and procedure derived from data captured during recordings and interviews.

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Professor Geraldine Boylan

Other

Registry information

Official study title

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

Acronym: NBT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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