Neonatal SeizureNCT04991779
AI-assisted cEEG Diagnosis of Neonatal Seizures in Neonatal Intensive Care Unit
An observational study of Neonatal Seizure, run by Children's Hospital of Fudan University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Seizure
- What is being tested?
- AI-assisted cEEG detection tool
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 16 Mar 2022to 16 May 2022
- Phase
- Observational
- 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 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with suspected seizures and high risk of seizures
Who may be able to join
- Postnatal age < or = 28 days;
- cEEG monitoring at least 12hours monitoring;
- Suspected seizures;
- Risk of Intracranial hemorrhage;
- Abnormality of MRI or ultrasound before cEEG;
- Neonates diagnosed with encephalopathy or suspected of encephalopathy;
Show all 11Show fewer
- Hypoxic-ischemic encephalopathy or suspected hypoxic-ischemic encephalopathy;
- Metabolic disturbances (Hypoglycemia, Hypocalcemia, Hypomagnesemia, Inborn errors of metabolism);
- Central nervous system (CNS) or systemic infections;
- Postsurgical neonatal within 3 days;
- Suspected genetic disease 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.
China3 sites
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Henan Children's Hospital
Zhengzhou, Henan
About this study
Official title: A Multicenter Diagnostic Study on the Utility of AI-assisted Continue EEG Diagnosis of Neonatal Seizures
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.
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 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
- Being tested
- AI-assisted cEEG detection tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted cEEG detection toolDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| The neonates with suspected seizures or high risk of seizures | 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. Receives: Diagnostic Test: AI-assisted cEEG detection tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 7 days since the end of cEEG monitoring during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start16 Mar 2022
- Primary completion16 May 2022
- Study completion16 May 2022
Why it stopped: 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.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
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
- Responsible party
- Sponsor
- Investigators
- Wenhao Zhou, Ph.D, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991779
- Sponsor's protocol ID
- CHFudanU_NNICU16
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2021
- Last updated
- 29 Dec 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Diagnostic Study on the Utility of AI-assisted Continue EEG Diagnosis of Neonatal Seizures
- ClinicalTrials.gov ID
- NCT04991779
- Acronym / sponsor ID
- CHFudanU_NNICU16
- Conditions
- Neonatal Seizure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- 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
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 5 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The neonates with suspected seizures or high risk of seizures | – | Diagnostic Test: AI-assisted cEEG detection toolThe 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with suspected seizures and high risk of seizures
Key inclusion criteria (11 listed)
- Postnatal age < or = 28 days;
- cEEG monitoring at least 12hours monitoring;
- Suspected seizures;
- Risk of Intracranial hemorrhage;
- Abnormality of MRI or ultrasound before cEEG;
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 |
|---|---|---|
| AI-assisted cEEG detection toolThis 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. | Diagnostic test | The neonates with suspected seizures or high risk of seizures |
Primary outcome
The accuracy of AI-assisted cEEG diagnostic tool in evaluating the neonatal seizure
Time frame: within 7 days since the end of cEEG monitoring during hospitalization
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal 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.
Wenhao Zhou, Ph.D 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?
An observational study of 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 11 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: withdrawn, as of the sponsor's last update on 29 Dec 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of AI-assisted cEEG diagnostic tool in evaluating the neonatal seizure (time frame: within 7 days since the end of cEEG monitoring during hospitalization). 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 NCT04991779, 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 29 Dec 2023.