Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
研究概览
简要总结
The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.
Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
- •Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).
排除标准
- •Moderate to life threatening fetal anomalies
- •Multiple live gestations at birth (e.g. twins, triplets, etc)
- •Intrauterine fetal demise
- •Previous participation
- •Stem cell collection
结局指标
主要结局
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
时间窗: 3 years
次要结局
- Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.(3 years)
