A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Baseline Retic Count
研究概览
简要总结
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard three times weekly dosing.
详细描述
Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm infants.
Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARC), transfusions, phlebotomy losses, and adverse events were recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 100 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< or = 1,500 grams
- •< or = 32 weeks gestation
- •> or = 7 days of age
- •informed consent obtained
排除标准
- •hemolytic disease
- •hypertension
- •thromboses
- •major malformation
研究组 & 干预措施
three times weekly Epo
Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
干预措施: three times weekly Epo (Drug)
weekly Epo
1,200 units/kg given once a week subcutaneously for 4 weeks
干预措施: weekly Epo (Drug)
结局指标
主要结局
Baseline Retic Count
时间窗: baseline
retic count measured at study entry
Reticulocyte Count
时间窗: 4 weeks
reticulocyte count at 4 weeks (end of study)
次要结局
未报告次要终点