Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial)

项目总结 我们建议进行一项研究，看看对那些需要复苏的婴儿进行脐带挤奶(UCM)是否 比在出生时立即夹住并切断脐带要好。我们想知道它是否会减少死亡 和/或进入NICU。此外，我们认为它可以通过以下方式减少幸存者的发育问题 两岁的孩子。 在婴儿出生时，迅速开始呼吸是至关重要的。婴儿必须从依赖于 胎盘第一次使用氧气来使用它的肺。在世界范围内，每年有近1000万婴儿没有 出生时立即呼吸，这些婴儿中约有600万需要复苏。通常的做法是 需要复苏的婴儿是立即夹住脐带。动物研究表明，夹住 婴儿呼吸前的脐带会导致心跳减慢，从而减少出血量。 每分钟都被从心脏中抽出。这项研究将测试婴儿是否会从UCM中受益。那根绳子 将在切割前快速挤奶四次，不会延误复苏程序。这项研究是 重要的是，当需要复苏时，无论是UCM还是延迟的脐带夹闭都不是 由于缺乏证据，被国家和国际组织推荐。然而，几项大型研究 来自世界各地的研究人员发现，需要复苏的婴儿更有可能出现以下情况 如脑瘫、自闭症等发育问题。大量的胎儿血液留在了 立即夹住脐带后的胎盘意味着婴儿大脑、肺和心脏获得的血液更少， 这可能会导致脑损伤甚至死亡。出生时的脐带挤奶可能通过以下方式帮助保护这些婴儿 增加输血量。我们之前的工作表明，与立即夹住脐带相比， UCM的结果是心率、血压更好，早期贫血更少，大脑中的氧气更多。无伤大雅 在任何研究中都已注意到来自UCM的。 我们将使用这样一种设计，即每个医院将被随机分配使用两种即刻脐带 对于任何需要在12个月内复苏的婴儿，可进行钳夹或UCM。则站点将更改为 其他方法再延长12个月。父母将在婚前被告知试验情况，并被邀请参加 在出生后，如果他们的婴儿符合条件。这项试验将涉及620名8岁时需要复苏的足月新生儿。 (8)加利福尼亚州圣地亚哥、加利福尼亚州拉梅萨、加利福尼亚州洛玛琳达、加利福尼亚州华盛顿特区戴维斯和加拿大的医院。这 试验将提供证据，以促进改变支持UCM使用的指南--一种简单、免费的方法 干预作为对需要复苏的足月和近期新生儿的标准护理。

PROJECT SUMMARY 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 admission to the NICU. In addition, we believe it may reduce developmental problems in survivors by two years of age. 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, almost 10 million babies do not breathe immediately at birth, and about 6 million of these infants need resuscitation. 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. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. 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 from around the world have identified that infants needing resuscitation are more likely to 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 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 12 months. Then sites will change to the other method for an additional 12 months. Parents will be informed about the trial prenatally and invited to join after birth if their infant qualifies. This trial will involve 620 term newborns needing resuscitation at birth at eight (8) hospitals in San Diego, CA; La Mesa, CA; Loma Linda, CA; Davis, CA Washington, DC; and Canada. 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.