Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- transfusion need
研究概览
简要总结
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.
Study population: 219 patient randomized into 3 groups
详细描述
Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremely low birth weight infants
排除标准
- •Cyanotic heart disease
- •Major congenital malformation requiring surgery
- •Gestational age > 30 weeks
- •Administration of an investigational drug during pregnancy
- •Lack of parental consent
研究组 & 干预措施
2: late rhEPO
late EPO treatment from the fourth week for 6 weeks
干预措施: epoetin beta (Drug)
1: early rhEPO
early rhEPO treatment from the first week until 9 weeks
干预措施: epoetin beta (Drug)
结局指标
主要结局
transfusion need
时间窗: 9 weeks
次要结局
- concentrations of trace elements and antioxidant enzymes in the blood(9 weeks)