Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- structural changes of brain injury
研究概览
简要总结
Infection and inflammation is related to increased encephalopathy of prematurities.
详细描述
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants with encephalopathy
排除标准
- •refuse the participate in the trial
研究组 & 干预措施
human gamma globulin
human gamma globulin for infants with encephalopathy of prematurities
干预措施: human gamma globulin (Drug)
human gamma globulin
human gamma globulin for infants with encephalopathy of prematurities
干预措施: non-human gamma globulin (Drug)
non-human gamma globulin
non-human gamma globulin for infants with encephalopathy of prematurities
干预措施: human gamma globulin (Drug)
non-human gamma globulin
non-human gamma globulin for infants with encephalopathy of prematurities
干预措施: non-human gamma globulin (Drug)
结局指标
主要结局
structural changes of brain injury
时间窗: 100-days
MRI/ultrasound will be used to assess the structural severities of brain injury.
functional changes of brain injury
时间窗: 100-days
Bayley score will be used to assess the functional severities of brain injury.
次要结局
未报告次要终点
研究者
Fang Wu
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University