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Newborn Brain Test (NBT)

NCT06580834 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Seizures Newborn
  • Brain Injuries

Interventions

DEVICE

Cergenx Wave

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

Sponsors & Collaborators

  • Professor Geraldine Boylan

    lead OTHER

Principal Investigators

  • Geraldine Boylan, Professor · University College Cork INFANT Centre

Eligibility

Min Age
37 Weeks
Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2025-01-29
Completion
2025-02-04

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580834 on ClinicalTrials.gov