Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- total antioxidant capacity
研究概览
简要总结
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.
详细描述
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature neonates ≤36 weeks in need for blood transfusion.
排除标准
- •Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
- •Extremely low birth weight neonates(<1000gm birth weight )
- •Recipient of blood transfusion before enrollment in the study.
- •Neonates planned for exchange transfusion .
结局指标
主要结局
total antioxidant capacity
时间窗: 2-3 hours posttransfusion
TAC
serum Copper
时间窗: 2-3 hours posttransfusion
s.Cu
serum iron
时间窗: 2-3 hours posttransfusion
s.Fe
serum Calcium
时间窗: 2-3 hours posttransfusion
s.Ca
serum Zinc
时间窗: 2-3 hours posttransfusion
s.Zn
malondialdehyde
时间窗: 2-3 hours posttransfusion
MDA
serum magnesium
时间窗: 2-3 hours posttransfusion
s.Mg
次要结局
未报告次要终点
研究者
Rania Ali El-Farrash
Clinical Professor
Ain Shams University