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EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy

NCT05079971 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-08-14

No results posted yet for this study

Summary

The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full or continuous electroencephalography (cEEG) is superior to amplitude-integrated electroencephalography (aEEG) in the real time evaluation and diagnosis of neonatal seizures and in reducing time to treatment. At-risk new-born infants will be recruited on the participating neonatal intensive care units (NICUs) by trained specialist staff and will have 24 hours of EEG monitoring.

Conditions

  • Neonatal Seizures

Interventions

DIAGNOSTIC_TEST

Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology

In group B, the standart-care equivalent aEEG review is undertaken by NICU staff via a 2-channel display. In addition to the standard care, concurrent full EEG is reviewed remotely with regular feedback by a specialist trained clinical neurophysiologist. The clinical neurophysiology reports only on seizure burden, no information or direction is provided regarding clinical management.

Sponsors & Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Luton and Dunstable Hospital NHS Foundation Trust

    collaborator UNKNOWN

  • Infant, University College Cork, Ireland

    collaborator UNKNOWN

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • United Kingdom

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 NCT05079971 on ClinicalTrials.gov