Seizures NewbornNBTNCT06580834
Newborn Brain Test (NBT)
An observational study of Seizures Newborn and Brain Injuries, run by Professor Geraldine Boylan at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 45 weeksHealthy volunteers can take part
- Conditions the study is for
- Seizures Newborn, Brain Injuries
- What is being tested?
- Cergenx Wave
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteIreland
- Study dates
- 22 Jul 2024to 4 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 45 weeks
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- All neonates≥ 37 and ≤45 weeks gestational age
- Parental informed consent
Who cannot join
- Any Infant with head trauma or broken skin on the scalp
- Informed consent not obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Newborn Brain Test (NBT): Assessment of Newborn Brain Function Using Automated AI Assessment, Phase1 Feasibility Study
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.
Read the 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
- Being tested
- Cergenx Wave
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cergenx WaveDevice
Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cergenx Wave | |
| 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. Receives: Device: Cergenx Wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start22 Jul 2024
- Primary completion29 Jan 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizures NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Geraldine Boylan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Geraldine Boylan, University College Cork
- Investigators
- Geraldine Boylan, Professor, Study director, University College Cork INFANT Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580834
- Sponsor's protocol ID
- ECM 4 (tt) 05/12/2023
- Acronym
- NBT
- Status last verified
- Apr 2025
- First submitted
- 24 Jul 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Brain Test (NBT): Assessment of Newborn Brain Function Using Automated AI Assessment, Phase1 Feasibility Study
- ClinicalTrials.gov ID
- NCT06580834
- Acronym / sponsor ID
- NBT / ECM 4 (tt) 05/12/2023
- Conditions
- Seizures Newborn, Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Professor Geraldine BoylanUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal Intensive care Unit | – | Device: Cergenx Wave50% 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. |
| Post Natal Ward | – | Device: Cergenx Wave50% 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. |
Who may qualify
- Ages
- 37 to 45 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- All neonates≥ 37 and ≤45 weeks gestational age
- Parental informed consent
Key exclusion criteria (2 listed)
- Any Infant with head trauma or broken skin on the scalp
- Informed consent not obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cergenx WaveShort EEG recording using EEG amplifier with cloud based algorithm to assess brain injury. | Device | Neonatal Intensive care Unit, Post Natal Ward |
Primary outcome
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.
4 secondary outcomes
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
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
Number of attempts by a user before a good quality recording is achieved (Max 3 attempts)
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Boylan, Professor study director
University College Cork INFANT Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures Newborn and Brain Injuries, run by Professor Geraldine Boylan at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.