NCT04991779

AI-assisted cEEG Diagnosis of Neonatal Seizures in Neonatal Intensive Care Unit

A Multicenter Diagnostic Study on the Utility of AI-assisted Continue EEG Diagnosis of Neonatal Seizures

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

A diagnostic accuracy study on Artificial intelligence assisted continue EEG diagnostic tool is to carried out comparing with manually EEG interpretation as the golden standard for neonatal seizure.

Detailed description

The occurrence of neonatal seizures may be the first, and perhaps the only, clinical sign of a central nervous system disorder in the newborn infant. The incidence of neonatal seizures is variable based on gestational age. The etiology of seizures may indicate the presence of a potentially treatable etiology and should prompt an immediate evaluation to determine the cause and to initiate etiology-specific therapy. Importantly, the earlier treatment of seizures positively affects the infant's long-term neurological development. However, even when continue electroencephalogram (cEEG) monitoring is available, the availability of on-site expertise to interpret cEEG signals is limited and in practice, the diagnosis is still based only on clinical signs. The previous study indicated that the reliable seizure detection was as little as 10% of seizure events. Therefore, an early automated seizure detection tool has been developed based on machine learning. The lack of an automated seizure detection tool has been validated in the external neonatal seizures cohort. The evidence on the utility of the automated seizure detection tool remains uncertain. This is a prospective, continuous double-blind designed diagnostic accuracy study. The study aims to validate the accuracy of the artificial intelligence (AI)-assisted cEEG diagnostic tool comparing the manually cEEG interpretation as the golden standard of neonatal seizure in neonatal intensive care units. Analysis of sensitivity and specificity is to evaluate the accuracy of AI-assisted cEEG diagnostic tool.

Conditions

• Neonatal Seizure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI-assisted cEEG detection tool	This study is an observational study to evaluate the accuracy of AI-assisted cEEG diagnostic tool with routine care. All patients from the cohort accept cEEG monitoring and AI-assisted cEEG detection tool. The tool included a quantitive EEG neural signal processing pipeline to extract features from the original signal datasets, machine learning models based on gradient boosted model for prediction. The reference standard is the electrographic seizures interpreted by 3 clinicians who had attended the uniformly training program and were certified by the Chinese Anti-Epilepsy Association.

Timeline

• Start date: 2022-03-16
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2021-08-05
• Last updated: 2023-12-29

Locations

3 sites across 1 country: China