NCT04249193已完成不适用
Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Change in number of Intermittent hypoxia
研究概览
简要总结
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23+0 to 28+6 weeks gestational age at birth
排除标准
- •Infants with life-limiting diagnoses
- •Cyanotic heart disease
- •In utero fetal transfusion
- •Twin to twin transfusion syndrome
- •Isoimmune hemolytic disease
- •Severe acute hemorrhage
- •Acute shock
- •Sepsis with coagulopathy
- •Need for perioperative transfusion
- •Parents opposed to transfusion of blood
- •Parents with hemoglobinopathy or congenital anemia
结局指标
主要结局
Change in number of Intermittent hypoxia
时间窗: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).
An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for \>/= 10 secs and \<3 minutes with a minimal time interval of 4 seconds between events.
次要结局
- Hypoxia(8 hours prior to transfusion and 8 hours after transfusion.)
研究者
Kelley Kovatis
Attending Neonatologist
Christiana Care Health Services
研究点 (3)
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