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The Effect of AI-assisted cEEG Diagnosis on the Administration of Antiseizure Medication in Neonatal Seizures

NCT05036395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-04-04

No results posted yet for this study

Summary

This is a prospective randomised clinical trial study to test an artificial intelligence (AI)-assisted continuous electroencephalogram(cEEG) diagnostic tool for optimizing the administration of antiseizure medication (ASM) in neonatal intensive care units(NICUs).

Conditions

  • Neonatal Seizure

Interventions

OTHER

The routine assessment protocol and AI-assisted cEEG Diagnostic tool

The AI-assisted cEEG diagnostic tool is an automated seizure reporting system, including a quantitively EEG neural signal processing pipeline to extract features from the original signal datasets, machine learning models based on gradient boosted model for prediction. The tool can report electrographic seizures in real time during cEEG monitoring. The neonatologists will evaluate the neonates by AI-assisted cEEG diagnostic tool, clinical conditions, real-time cEEG and amplitude-integrated EEG traces. The investigators will make a decision after review the neonates clinical conditions, AI-assisted cEEG diagnostic report, the cEEG and amplitude-integrated EEG.

OTHER

The routine assessment protocol

The routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces.

Sponsors & Collaborators

  • Chengdu Women's and Children's Central Hospital

    collaborator OTHER

  • Xiamen Children's Hospital

    collaborator OTHER

  • Kunming Children's Hospital

    collaborator OTHER

  • The Affiliated Hospital Of Southwest Medical University

    collaborator OTHER

  • Children's Hospital of Zhengzhou University

    collaborator UNKNOWN

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Wenhao Zhou · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2024-03-10
Completion
2024-03-10

Countries

  • China

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 NCT05036395 on ClinicalTrials.gov