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临床试验/NCT01426698
NCT01426698已完成2 期

18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

University of Rhode Island2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
208
试验地点
2
主要终点
Motor function

研究概览

简要总结

The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

详细描述

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate).

Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
24 Weeks 至 31 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • pregnancy between 24 and 31.6 weeks
  • singleton fetus
  • threatened preterm birth.

排除标准

  • Fetuses: congenital anomalies
  • Mothers: severe or multiple maternal illnesses
  • Drug users or institutionalized or psychotic women

结局指标

主要结局

Motor function

时间窗: 18-22 months

Very low birth weight infants in the delayed cord-clamping group will have better motor function at 18-22 months corrected age when compared with VLBW infants in the ICC group.

次要结局

  • Mental Functioning(18 to 22 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith S Mercer

Clinical Professor

University of Rhode Island

研究点 (2)

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