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

Primary Purpose

Neonatal Seizure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The routine assessment protocol and AI-assisted cEEG Diagnostic tool
The routine assessment protocol
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neonatal Seizure

Eligibility Criteria

0 Days - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postnatal age < or = 28 days;
  • cEEG monitoring at least 24hours monitoring;
  • Suspected seizures;
  • Abnormal movement;
  • Brain infarction;
  • Risk of Intracranial hemorrhage;
  • Abnormality of brain MRI or ultrasound;
  • Hypoxic-ischemic encephalopathy or suspected Hypoxic-ischemic encephalopathy;
  • Central nervous system (CNS) or systemic infections;
  • Suspected genetic diseases or Positive genetic diagnoses;

Exclusion Criteria:

  • The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.

Sites / Locations

  • Henan Children's HospitalRecruiting
  • Children Hospital of Fudan University
  • Chengdu Women's and Children's Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The neonates evaluated by the routine assessment protocol and AI-assisted cEEG Diagnostic tool

The neonates evaluated by the routine assessment protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gesell Developmental Schedules (GDS)
The GDS comprise comprehensive checklists for assessing neuromotor wholeness, functional maturity, and mental development of infants and toddlers from the perspectives of adaptability, large exercise, fine motor skills, language, and personal-social networking. The GDS score provides an objective assessment of neurological and mental development in this age group.
Total electrographic seizure times per hour (second/hour)
Total electrographic seizure times per hour (second/hour) is defined as total duration of all seizures in every hour from the start of the EEG monitoring to the end of the cEEG monitoring.
The mortality of neonates
The proportion of the deceased neonates

Full Information

First Posted
August 24, 2021
Last Updated
April 3, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Chengdu Women's and Children's Central Hospital, Xiamen Children's Hospital, Kunming Children's Hospital, The Affiliated Hospital Of Southwest Medical University, Children's Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05036395
Brief Title
The Effect of AI-assisted cEEG Diagnosis on the Administration of Antiseizure Medication in Neonatal Seizures
Official Title
AI-assisted cEEG Diagnosis of Neonatal Seizures to Optimize the Administration of Antiseizure Medication: a Multicenter, Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Chengdu Women's and Children's Central Hospital, Xiamen Children's Hospital, Kunming Children's Hospital, The Affiliated Hospital Of Southwest Medical University, Children's Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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 promoted treatment of seizures can limit the secondary injury to the brain and positively affect the infant's long-term neurological development. However, the current antiseizure medication (ASM) are both overused and underused. Studies indicated that early automated seizure detection tool had a high diagnostic accuracy of neonatal seizures. However, there is little evidence that early automated seizure detection tool could the optimize the administration of ASM and improved the neurological outcomes in neonatal seizures. Therefore, the primary study aim is to investigate whether the utility of AI assisted cEEG diagnostic tool could optimize the administration of ASM in NICUs. This project will enroll the neonates with suspected or high risk of seizures who will receive at least 72 hours cEEG monitoring during hospitalization. All the cEEG monitoring methodology is standardized across recruiting hospitals. The intervention will be an artificial intelligence (AI)-assisted continues electroencephalogram (cEEG) diagnostic tool. The individuals were randomly allocated to one of the two groups using a predetermined randomisation sequence and block randomisation generator (block of 4). The group 1 will be monitored with cEEG and the cEEG recording will be assessed by neonatologists with AI assisted cEEG diagnostic tool in real time during cEEG monitoring. The group 2 will be monitored with cEEG and the cEEG recording will be assessed by neonatologists when as routine during cEEG monitoring. Both groups will follow the standard clinical protocols for ASM administration of the recruiting hospitals 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. These 3 clinicians are blinded to the group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Seizure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The neonates evaluated by the routine assessment protocol and AI-assisted cEEG Diagnostic tool
Arm Type
Experimental
Arm Description
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.
Arm Title
The neonates evaluated by the routine assessment protocol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The routine assessment protocol and AI-assisted cEEG Diagnostic tool
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The routine assessment protocol
Intervention Description
The routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces.
Primary Outcome Measure Information:
Title
The percentage of the individuals with the inappropriate administration of ASM
Description
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.
Time Frame
Immediately after the end of cEEG monitoring
Secondary Outcome Measure Information:
Title
Gesell Developmental Schedules (GDS)
Description
The GDS comprise comprehensive checklists for assessing neuromotor wholeness, functional maturity, and mental development of infants and toddlers from the perspectives of adaptability, large exercise, fine motor skills, language, and personal-social networking. The GDS score provides an objective assessment of neurological and mental development in this age group.
Time Frame
at corrected gestational age of 6 months
Title
Total electrographic seizure times per hour (second/hour)
Description
Total electrographic seizure times per hour (second/hour) is defined as total duration of all seizures in every hour from the start of the EEG monitoring to the end of the cEEG monitoring.
Time Frame
Immediately after the end of cEEG monitoring
Title
The mortality of neonates
Description
The proportion of the deceased neonates
Time Frame
Immediately after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postnatal age < or = 28 days; cEEG monitoring at least 24hours monitoring; Suspected seizures; Abnormal movement; Brain infarction; Risk of Intracranial hemorrhage; Abnormality of brain MRI or ultrasound; Hypoxic-ischemic encephalopathy or suspected Hypoxic-ischemic encephalopathy; Central nervous system (CNS) or systemic infections; Suspected genetic diseases or Positive genetic diagnoses; Exclusion Criteria: The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhao Zhou, Ph.D
Phone
+86-21-64931913
Email
zhouwenhao@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tiantian Xiao, M.D
Email
xiao13671814745@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhao Zhou
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Henan Children's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Guo, MD
Facility Name
Children Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhao Zhou, Doctor
Phone
(+86)021-64931003
Email
zwhchfu@126.com
Facility Name
Chengdu Women's and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhong Hu

12. IPD Sharing Statement

Citations:
PubMed Identifier
30472660
Citation
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.
Results Reference
result
PubMed Identifier
22146359
Citation
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.
Results Reference
result
PubMed Identifier
33323492
Citation
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.
Results Reference
result

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

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