The other study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
A Multicenter Diagnostic Study on the Utility of AI-assisted Continue EEG Diagnosis of Neonatal Seizures
Sponsor study identifier
observational
0
1 country
3
Study Start
March 16, 2022
Actual (reported)Primary Completion
May 16, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 16, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2021
Actual (reported)August 5, 2021
Actual (reported)March 16, 2022
Actual (reported)May 16, 2022
Actual (reported)May 16, 2022
Actual (reported)The accuracy of AI-assisted cEEG diagnostic tool in evaluating the neonatal seizure
The accuracy of includes sensitivity and specificity. 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. Sensitivity is defined as: The proportion of neonates with seizures is successfully screened out by AI-assisted cEEG diagnostic tool. Specificity is defined as: The proportion of neonates without seizures who are not recognized as seizures by AI-assisted cEEG diagnostic tool.
within 7 days since the end of cEEG monitoring during hospitalization
The neonates with suspected seizures or high risk of seizures are monitored by continuous electroencephalogram (cEEG) at least 12 hours since admission. The cEEG will be interpreted by AI-assisted cEEG diagnostic tool at the end of cEEG monitoring. At the same time, the same cEEG will be manually reported according the reference standard.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neonates with suspected seizures and high risk of seizures
Henan Children's Hospital
Zhengzhou, Henan, China
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Livingstone V, van Huffelen AC, Mathieson SR, Pavlidis E, Weeke LC, Toet MC, Finder M, Pinnamaneni RM, Murray DM, Ryan AC, Marnane WP, Boylan GB. Characterisation of neonatal seizures and their treatment using continuous EEG monitoring: a multicentre experience. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F493-F501. doi: 10.1136/archdischild-2018-315624. Epub 2018 Nov 24.
Shellhaas RA, Chang T, Tsuchida T, Scher MS, Riviello JJ, Abend NS, Nguyen S, Wusthoff CJ, Clancy RR. The American Clinical Neurophysiology Society's Guideline on Continuous Electroencephalography Monitoring in Neonates. J Clin Neurophysiol. 2011 Dec;28(6):611-7. doi: 10.1097/WNP.0b013e31823e96d7. No abstract available.
Wenhao Zhou, Ph.D
Children's Hospital of Fudan University
0 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2021
First Posted
August 5, 2021
Study Start
March 16, 2022
Actual (reported)Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures
Contact the study team to confirm eligibility.
Hoodbhoy Z, Masroor Jeelani S, Aziz A, Habib MI, Iqbal B, Akmal W, Siddiqui K, Hasan B, Leeflang M, Das JK. Machine Learning for Child and Adolescent Health: A Systematic Review. Pediatrics. 2021 Jan;147(1):e2020011833. doi: 10.1542/peds.2020-011833. Epub 2020 Dec 15.
Primary Completion
May 16, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)Last Updated
December 29, 2023
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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