A Cluster Randomized Clinical Trial of Umbilical Cord Milking to Improve Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth

项目总结 在婴儿出生时，迅速开始呼吸是至关重要的。婴儿必须改变对胎盘的依赖 让氧气第一次使用它的肺。全世界每年有1000万婴儿不能立即呼吸 在低收入和中等收入国家，每年大约有100万婴儿死于大脑 新生儿脑血流和氧气供应不足造成的损伤，这种情况称为缺氧 缺血性脑病(HIE)。需要复苏的婴儿通常的做法是立即夹住 脐带。动物研究表明，在婴儿呼吸之前夹住脐带会导致心脏跳动 心脏跳动减慢，可以减少每分钟从心脏泵出的血量。我们提出了一个 关于对那些需要复苏的婴儿进行脐带挤奶(UCM)是否比立即进行更好的研究 出生时夹住并切断脐带。我们想知道它是否会减少死亡和/或HIE。此外，它还可能 将幸存者的发育问题减少两岁。这项研究很重要，因为当有 国内和国际上都建议进行复苏，无论是UCM还是延迟夹住脐带 组织由于缺乏证据。然而，来自世界各地的几项大型研究发现，婴儿 需要复苏的人更有可能死亡或发展为脑瘫、自闭症和其他疾病 发育问题。即刻夹住脐带后胎盘内残留大量胎儿血 意味着婴儿获得的大脑、肺和心脏的血液较少，这可能会导致脑损伤和 甚至是死亡。出生时的脐带挤奶可能通过增加输血量来帮助保护这些婴儿。 我们先前的工作已经表明，与立即夹住脐带相比，UCM可以产生更好的心率、血液 血压，较少的早期贫血，以及大脑中更多的氧气。足月儿中未发现UCM的危害 在任何研究中。 我们将使用这样一种设计，即每个医院将被随机分配为使用立即脐带夹闭或 UCM适用于任何需要复苏超过6个月的婴儿。则站点将更改为其他方法 再延长6个月。这项试验将涉及3442名在出生时患有抑郁症的足月新生儿。 印度的医院。这项试验将提供证据，以促进改变支持UCM使用的指南 -一种简单、免费的干预措施，作为需要复苏的足月和近期新生儿的标准护理。

PROJECT SUMMARY At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. Worldwide each year, 10 million babies do not breathe immediately at birth, and approximately one million babies die annually in low and middle-income countries due to a brain injury caused by inadequate blood flow and oxygen delivery to the neonatal brain, a condition known as hypoxic ischemic encephalopathy (HIE). The usual practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. We propose a study to see if umbilical cord milking (UCM) for those infants who need resuscitation is better than immediately clamping and cutting the umbilical cord at birth. We wonder if it will reduce death and/or HIE. In addition, it may reduce developmental problems in survivors by two years of age. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies fromaround the world have identified that infants needing resuscitation are more likely to die or develop conditions such as cerebral palsy, autism and other developmental problems. The large amount of fetal blood left in the placenta after immediate cord clamping means that the baby gets less blood for the brain, lungs, and heart, which can contribute, to brain injury and even death. Cord milking at birth may help to protect these infants by increasing the transfer of blood volume. Our prior work has shown that, compared to immediate cord clamping, UCM results in better heart rate, blood pressure, less early anemia, and more oxygen in the brain. No harm from UCM has been noted in term infants in any studies. We will use a design in which each hospital will be randomly assigned to use either immediate cord clamping or UCM for any infant needing resuscitation over a period of 6 months. Then sites will change to the other method for an additional 6 months. This trial will involve 3442 term newborns who are depressed at birth at seven (7) hospitals in India. This trial will provide evidence to promote a change in guidelines supporting the use of UCM – a simple, no-cost intervention as standard of care in term and near-term newborns needing resuscitation.