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

Fudan University

Status: Enrolling

Conditions: Neonatal Seizure

Treatments: Other: The routine assessment protocol; Other: The routine assessment protocol and AI-assisted cEEG Diagnostic tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05036395

CHFudanU_NNICU17

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Other: The routine assessment protocol and AI-assisted cEEG Diagnostic tool

The neonates evaluated by the routine assessment protocol

Active Comparator group

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.

Treatment:

Other: The routine assessment protocol