Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.
详细描述
Blood transfusions have many risks including transfusion reactions and infections. Cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (LBW) premature newborns. However, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW premature newborns is still insufficient.
A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks' gestational age and processed into autologous RBC products. Infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. Two randomized groups were compared on the 14th, 28th, 35th days and >35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were developmentally assessed by the end of the postnatal first year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at ≤ 32 weeks gestational age
- •Parental consent
排除标准
- •rhesus incompatibility
- •hydrops fetalis
- •maternal viral or bacterial infections including suspected chorioamnionitis
- •parental refuse
结局指标
主要结局
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
时间窗: one year
次要结局
- The hemoglobin levels at postnatal 35th days(35 days)
- The hemoglobin levels at postnatal 14th days(14 days)
- The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks(3 months)
- The hemoglobin levels at postnatal 28th days(28 days)
- The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks(5 months)
- Developmental assessments of infants(One year)