AI-assisted cEEG Diagnosis of Neonatal Seizures to Optimize the Administration of Antiseizure Medication: a Multicenter, Randomised, Controlled Trial
Sponsor study identifier
interventional
1,000
1 country
3
Study Start
March 16, 2022
Actual (reported)Primary Completion
March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2021
Actual (reported)September 5, 2021
Actual (reported)March 16, 2022
Actual (reported)March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The percentage of the individuals with the inappropriate administration of ASM
The inappropriate administration of ASM is defined: (1) the administration of an ASM before the electrographic seizure episode; or (2) an ASM is given to the neonates without electrographic seizure episode.
Immediately after the end of cEEG monitoring
Gesell Developmental Schedules (GDS)
at corrected gestational age of 6 months
Total electrographic seizure times per hour (second/hour)
Immediately after the end of cEEG monitoring
The mortality of neonates
Immediately after discharge
This group will be monitored by cEEG with standard operating procedure. The cEEG recording will be evaluated by neonatologists with the routine assessment protocol and AI assisted cEEG diagnostic tool in real time during cEEG monitoring. Both real-time cEEG and amplitude-integrated EEG traces are displayed at the bedside for clinical review. This group will follow the standard clinical protocols of the recruiting hospitals for ASM administration after the neonatologists' review.
This group will be monitored by cEEG with standard operating procedure. The cEEG recording will be evaluated by neonatologists with the routine assessment protocol during cEEG monitoring. Both real-time cEEG and amplitude-integrated EEG traces are displayed at the bedside for clinical review. This group will follow the standard clinical protocols of the recruiting hospitals for ASM administration after the neonatologists' review.
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.
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
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
Children's Hospital of Fudan University
First Submitted
August 24, 2021
First Posted
September 5, 2021
Study Start
March 16, 2022
Actual (reported)Primary Completion
March 10, 2024
Estimated (date passed)What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
The routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces.
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Chengdu, Sichuan, China
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 4, 2023
Record last verified: 2023-04
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