NCT02103296已完成不适用
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
Capt Alicia Prescott6 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Percent change in hemoglobin concentration from baseline
研究概览
简要总结
The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.
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
- None
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers
排除标准
- •No specific exclusion criteria
研究组 & 干预措施
Infant Blood
Active Comparator
Control group. Admission labs to be drawn directly from the infant.
干预措施: Drawing admission labs from infant blood (Procedure)
Cord Blood
Experimental
Admission labs to be drawn from the infant's cord blood
干预措施: Drawing admission labs from cord blood (Procedure)
结局指标
主要结局
Percent change in hemoglobin concentration from baseline
时间窗: 24 hours of life
Absolute hemoglobin concentration
时间窗: 24 hours of life
次要结局
- Hemoglobin concentration at one week of life(one week)
- Hemoglobin concentration at time of hospital discharge(Approximately 10 - 16 weeks)
- Number of blood donor exposures(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.)
- Use of Vasopressors(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.)
- Number/volume of packed red blood cell (pRBC) transfusions(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks)
- Head Ultrasound(Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age)
研究者
Capt Alicia Prescott
Associate Investogator
San Antonio Military Medical Center
研究点 (6)
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