AI-assisted cEEG Diagnosis of Neonatal Seizures to Optimize the Administration of Antiseizure Medication: a Multicenter, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- The percentage of the individuals with the inappropriate administration of ASM
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
结局指标
主要结局
The percentage of the individuals with the inappropriate administration of ASM
时间窗: 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.
次要结局
- Total electrographic seizure times per hour (second/hour)(Immediately after the end of cEEG monitoring)
- The mortality of neonates(Immediately after discharge)
- Gesell Developmental Schedules (GDS)(at corrected gestational age of 6 months)