Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580834
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Newborn Brain Test NBT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Newborn Brain Test NBT Assessment of Newborn Brain Function Using Automated AI Assessment Phase1 Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NBT
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 INFANTs 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
NBT has been developed by INFANTs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None