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临床试验/NCT01018576
NCT01018576终止不适用

Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

University of California, Davis2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Initial body temperature

研究概览

简要总结

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

详细描述

Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 1 Minute(Child)
性别
All
接受健康志愿者

入选标准

  • premature infants at 24-28 completed weeks gestation at the time of delivery
  • informed consent obtained from parents prior to delivery

排除标准

  • multiple gestation (twins, triplets, etc)
  • prolonged fetal bradycardia
  • placental abruption or previa
  • maternal illness
  • major congenital anomalies
  • maternal fever in labor
  • fetal illness (e.g. isoimmune hemolysis)

结局指标

主要结局

Initial body temperature

时间窗: At birth

次要结局

  • Hematocrit at birth and 24 hours of age(first day of life)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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