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临床试验/NCT00818220
NCT00818220已完成2 期

Protective Effects of Delayed Cord Clamping in VLBW Infants

University of Rhode Island2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2008年2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
211
试验地点
2
主要终点
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group

研究概览

简要总结

The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.

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 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
  • Vaginal or cesarean birth

排除标准

  • Congenital anomaly
  • Multiple gestation
  • Intent to withhold or withdraw care
  • Severe or multiple maternal illnesses
  • Mothers who are institutionalized or psychotic

结局指标

主要结局

Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group

时间窗: December, 2012

Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group

时间窗: December 2012

次要结局

  • VLBW infants in the DCC group will have better motor function at 7 months corrected age(November 2012)

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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