NCT02954926已完成3 期
Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born alive before 37 weeks of pregnancy (preterm neonates)
- •Under 2500 g at birth
排除标准
- •lethal anomaly
- •congenital heart disease
- •TORCH infection
- •severe asphyxia
研究组 & 干预措施
IVIG
Experimental
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
干预措施: IVIG (Drug)
结局指标
主要结局
Mortality
时间窗: 7 days
Death from sepsis or its related complications
次要结局
- Total number of days of hospitalization(7 days)
- Intraventricular Hemorrhage(7 days)
- Necrotizing enterocolitis(7 days)
- Bronchopulmonary dysplasia(7 days)
研究者
Hamidreza Mahboobi
Resident of internal medicine
Hormozgan University of Medical Sciences
研究点 (1)
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