Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
2015年11月27日 更新者：Judith S Mercer、University of Rhode Island
Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
研究概览
详细说明
When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.
The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.
研究类型
介入性
注册 (实际的)
72
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rhode Island
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Providence、Rhode Island、美国、02905
- Women & Infants Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
- Obstetrician's approval of enrollment into study
- Parental consent
- Any mode of birth will be included
Exclusion Criteria:
- Obstetrician's refusal to enroll infants
- Parental refusal for consent
- Prenatally-diagnosed major congenital anomalies [or multiple gestations]
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
- Mothers who are institutionalized or psychotic
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：1-Immediate Cord Clamping
infants received the routine care of immediate clamping of the umbilical cord
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实验性的：2-Delayed Cord Clamping
after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.
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cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped
大体时间：36 wks postmenstrual age
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36 wks postmenstrual age
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VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group
大体时间：Hospital discharge
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Hospital discharge
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VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group
大体时间：7 months corrected age
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7 months corrected age
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group
大体时间：NICU stay
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NICU stay
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Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.
大体时间：NICU Stay
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NICU Stay
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Judith S Mercer, PhD, CNM、University of Rhode Island
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
- Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22.
- Mercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.2015.09.068. Epub 2015 Nov 4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年8月1日
初级完成 (实际的)
2005年11月1日
研究完成 (实际的)
2006年12月1日
研究注册日期
首次提交
2009年2月10日
首先提交符合 QC 标准的
2009年2月10日
首次发布 (估计)
2009年2月11日
研究记录更新
最后更新发布 (估计)
2015年11月30日
上次提交的符合 QC 标准的更新
2015年11月27日
最后验证
2015年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.