ACTRN12611000327987终止未知
A randomised controlled trial comparing the treatment of electrographic seizures and clinical seizures, to the treatment of clinical seizures alone, in term or near-term infants and measuring the impact on death and neurodevelopment at 2 years.
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 212
研究概览
简要总结
There were no significant differences between the two groups. Infants who had all electrographic seizures treated did not have improved mortality or neurodevelopment when compared to those infants who received standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Hours 至 48 Hours（—）
- 性别
- All
入选标准
- •Infants greater than or equal to 35 weeks' gestation (term or near term) admitted to a participating Neonatal Intensive Care Unit.
- •Less than or equal to 48 hours old:
- •A diagnosis of either:
- •-Neonatal encephalopathy including coma, stupor or depressed mental state (based on modified Sarnat classification II-III).
- •-Hypoxic-ischaemic encephalopathy or at risk for hypoxic-ischaemic encephalopathy (ie. 2 of the following - Apgar score less than 5 at 5 minutes); cord blood gas or postnatal blood gas within 1 hour of birth with a pH less than 7.1 or base excess < -12 within 1 hour of birth; need for ongoing respiratory support at 10 minutes after birth)
- •-suspected neonatal seizures
排除标准
- •Infants less than 35 weeks gestation;
- •Greater than 48 hours old;
- •Infants in non-convulsive status (as confirmed by conventional electroencephalography taken for one hour as soon as practical);
- •Infants diagnosed with Cerebral dysgenesis
研究者
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