Newborn Brain Test (NBT): Assessment of Newborn Brain Function Using Automated AI Assessment, Phase1 Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 37 Weeks 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All neonates≥ 37 and ≤45 weeks gestational age
- •Parental informed consent
排除标准
- •Any Infant with head trauma or broken skin on the scalp
- •Informed consent not obtained.
结局指标
主要结局
Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings
时间窗: 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.
次要结局
- Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt(Day 1)
- Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt.(Day 1)
- Number of attempts by a user before a good quality recording is achieved (Max 3 attempts)(Day 1)
- Assessment of healthcare satisfaction with useability of the device and procedure derived from data captured during recordings and interviews.(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)
研究者
Professor Geraldine Boylan
Professor
University College Cork