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

脐带挤奶可改善出生时活力不足的新生儿的短期和长期结果的集群随机临床试验

• 批准号: 10299878
• 负责人: ZUBAIR H AGHAI
• 金额: $ 58.74万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10299878
• 关键词: 2 year old; Affect; American; Anemia; Animals; Attention; Birth; Blood; Blood Pressure; Blood Volume; Blood flow; Brain; Brain Injuries; Breathing; Cardiovascular system; Cerebral Palsy; Cessation of life; Closure by clamp; Controlled Study; Country; Depressed mood; Development; Discipline of obstetrics; Enrollment; Ensure; Guidelines; Gynecology; Heart; Heart Rate; Hospitalization; Hospitals; Impairment; Incidence; Income; India; Individual; Infant; International; Intervention; Knowledge; Left; Lung; Magnetic Resonance Imaging; Methods; Milk; Neurodevelopmental Impairment; Newborn Infant; Outcome; Oxygen; Perfusion; Placenta; Process; Provider; Pump; Randomized; Randomized Clinical Trials; Resuscitation; Site; Survivors; Term Birth; Testing; Therapeutic; Time; Training; Transfusion; Umbilical Cord Blood; Umbilical cord structure; Work; World Health Organization; autism spectrum disorder; brain abnormalities; college; cost; design; disability; fetal blood; implementation cost; improved; intervention cost; low and middle-income countries; mortality; natural hypothermia; neonatal brain; neonatal hypoxic-ischemic brain injury; neonate; prevent; primary outcome; standard of care; treatment effect

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.

项目摘要 出生时，婴儿开始快速呼吸是至关重要的。婴儿必须从依赖胎盘 第一次用肺呼吸氧气全世界每年有1000万婴儿不能立即呼吸 在低收入和中等收入国家，每年约有100万婴儿死于脑损伤。 新生儿大脑的血流和氧气输送不足造成的损伤，这种情况称为缺氧 缺血性脑病。对于需要复苏的婴儿，通常的做法是立即夹住 脐带动物研究表明，在婴儿呼吸前夹住脐带会导致心脏 心跳变慢，可以减少每分钟从心脏泵出的血液量。我们提出了一个 一项研究，看看脐带挤奶（UCM）对于那些需要复苏的婴儿是否比立即更好 在出生时夹住并剪断脐带。我们想知道它是否会减少死亡和/或HIE。而且可大大 减少幸存者两岁时的发育问题。这项研究很重要，因为 需要复苏，无论是UCM或延迟脐带夹紧，是由国家和国际建议， 因为缺乏证据。然而，世界各地的几项大型研究表明， 需要复苏的人更有可能死亡或患上脑瘫、自闭症和其他疾病， 发展问题。立即脐带阻断后胎盘内残留大量胎儿血 这意味着婴儿的大脑、肺和心脏获得的血液减少，这可能导致脑损伤， 甚至死亡出生时脐带挤奶可能有助于通过增加血容量的转移来保护这些婴儿。 我们先前的工作表明，与立即脐带夹紧相比，UCM导致更好的心率，血液 血压，减少早期贫血，大脑中有更多的氧气。未发现UCM对足月儿有任何危害 在任何研究中。 我们将采用一种设计，其中每家医院将被随机分配使用立即脐带夹紧或 UCM适用于6个月内需要复苏的任何婴儿。然后，研究中心将更改为其他方法 再加6个月这项试验将涉及3442名足月新生儿，他们在出生时患有抑郁症， 印度的医院这项试验将提供证据，以促进改变支持使用UCM的指南 - 一种简单、无成本的干预措施，作为需要复苏的足月和近足月新生儿的标准护理。