Neonatal SeizureNCT05036395
The Effect of AI-assisted cEEG Diagnosis on the Administration of Antiseizure Medication in Neonatal Seizures
A study testing The routine assessment protocol and AI-assisted cEEG Diagnostic tool and The routine assessment protocol in people with Neonatal Seizure, run by Children's Hospital of Fudan University at 3 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 days to 6 months
- Conditions the study is for
- Neonatal Seizure
- What is being tested?
- The routine assessment protocol and AI-assisted cEEG Diagnostic tool and The routine assessment protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 16 Mar 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postnatal age < or = 28 days;
- cEEG monitoring at least 24hours monitoring;
- Suspected seizures；
- Abnormal movement;
- Brain infarction；
- Risk of Intracranial hemorrhage;
Show all 10Show fewer
- 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;
Who cannot join
- The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
Trial locations and contacts
3 sites in 1 country.
Tiantian Xiao, M.D contact
China3 sites, 3 recruiting
- Recruiting
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Xuhong Hu
- Not yet recruiting
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Wenhao Zhou, Doctor, (+86)021-64931003, zwhchfu@126.com
- Recruiting
Henan Children's Hospital
Zhengzhou, Henan
Jing Guo, MD
About this study
Official title: AI-assisted cEEG Diagnosis of Neonatal Seizures to Optimize the Administration of Antiseizure Medication: a Multicenter, Randomised, Controlled Trial
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).
Read the 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.
- Conditions
- Neonatal Seizure
- Being tested
- The routine assessment protocol and AI-assisted cEEG Diagnostic tool, The routine assessment protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The routine assessment protocol and AI-assisted cEEG Diagnostic toolOther
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.
The routine assessment protocolOther
The routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces.
| Study group | Role | What they receive |
|---|---|---|
| The neonates evaluated by the routine assessment protocol and AI-assisted cEEG Diagnostic tool | Experimental | 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. Receives: Other: The routine assessment protocol and AI-assisted cEEG Diagnostic tool |
| The neonates evaluated by the routine assessment protocol | Active comparator | 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. Receives: Other: The routine assessment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the end of cEEG monitoring
Secondary outcomes (3)
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.
Measured: at corrected gestational age of 6 months
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.
Measured: Immediately after the end of cEEG monitoring
The mortality of neonates
The proportion of the deceased neonates
Measured: Immediately after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start16 Mar 2022
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Women's and Children's Central Hospital, Xiamen Children's Hospital, Kunming Children's Hospital, The Affiliated Hospital Of Southwest Medical University, Zhengzhou Children's Hospital, China
- Responsible party
- Sponsor
- Investigators
- Wenhao Zhou, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036395
- Sponsor's protocol ID
- CHFudanU_NNICU17
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30472660Shellhaas 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.
PubMed 22146359Hoodbhoy 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.
PubMed 33323492
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-assisted cEEG Diagnosis of Neonatal Seizures to Optimize the Administration of Antiseizure Medication: a Multicenter, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT05036395
- Acronym / sponsor ID
- CHFudanU_NNICU17
- Conditions
- Neonatal Seizure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chengdu Women's and Children's Central Hospital, Xiamen Children's Hospital, Kunming Children's Hospital, The Affiliated Hospital Of Southwest Medical University, Zhengzhou Children's Hospital, China
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The neonates evaluated by the routine assessment protocol and AI-assisted cEEG Diagnostic tool | Experimental | Other: The routine assessment protocol and AI-assisted cEEG Diagnostic toolThis 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. |
| The neonates evaluated by the routine assessment protocol | Active comparator | Other: The routine assessment protocolThis 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. |
Who may qualify
- Ages
- 0 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Postnatal age < or = 28 days;
- cEEG monitoring at least 24hours monitoring;
- Suspected seizures；
- Abnormal movement;
- Brain infarction；
Key exclusion criteria (1 listed)
- The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The routine assessment protocol and AI-assisted cEEG Diagnostic toolThe 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 neonates evaluated by the routine assessment protocol and AI-assisted cEEG Diagnostic tool |
| The routine assessment protocolThe routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces. | Other | The neonates evaluated by the routine assessment protocol |
Primary outcome
The percentage of the individuals with the inappropriate administration of ASM
Time frame: Immediately after the end of cEEG monitoring
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.
3 secondary outcomes
Gesell Developmental Schedules (GDS)
Time frame: at corrected gestational age of 6 months
Total electrographic seizure times per hour (second/hour)
Time frame: Immediately after the end of cEEG monitoring
The mortality of neonates
Time frame: Immediately after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Results publication: PubMed 30472660Rennie 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 publication: PubMed 22146359Shellhaas 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 publication: PubMed 33323492Hoodbhoy 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.
Related trials for Neonatal Seizure
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingObservational study
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Not yet recruitingPhase 4
Treatment of Seizures in Neonate With HIE
Neonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiantian Xiao, M.D contact
Wenhao Zhou study chair
Children's Hospital of Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The routine assessment protocol and AI-assisted cEEG Diagnostic tool and The routine assessment protocol in people with Neonatal Seizure, run by Children's Hospital of Fudan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhao Zhou, Ph.D (+86-21-64931913, zhouwenhao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of the individuals with the inappropriate administration of ASM (time frame: Immediately after the end of cEEG monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036395, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.