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临床试验/NCT00562536
NCT00562536Unknown不适用

Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2007年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (2)

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