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

非活力婴儿的脐带挤奶（MINVI 试验）

• 批准号: 10188576
• 负责人: Anup C Katheria
• 金额: $ 59.16万
• 依托单位: SHARP MEMORIAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10188576
• 关键词: 2 year old; Admission activity; Adverse effects; Affect; American; Anemia; Animals; Attention; Attention deficit hyperactivity disorder; Birth; Blood; Blood Circulation; Blood Pressure; Blood Volume; Bradycardia; Brain; Brain Injuries; Brain Ischemia; Breathing; Canada; Cardiac; Cardiac Output; Cardiovascular system; Carotid Arteries; Cerebral Palsy; Cerebrovascular Circulation; Cerebrum; Cessation of life; Closure by clamp; Congresses; Delivery Rooms; Development; Emotional; Enrollment; Ensure; Guidelines; Gynecologist; Heart; Heart Rate; Hemoglobin concentration result; Hospitals; Hour; Hypoxia; Incidence; Individual; Infant; Infant Development; International; Intervention; Ischemia; Knowledge; Left; Life; Lung; Measures; Methods; Milk; Morbidity - disease rate; Neonatal Mortality; Newborn Infant; Outcome; Output; Oxygen; Parents; Perfusion; Physiological; Placenta; Populations at Risk; Positioning Attribute; Pregnancy; Premature Infant; Procedures; Pulmonary Circulation; Pump; Randomized; Research Personnel; Resuscitation; Risk Factors; Safety; Site; Survivors; Term Birth; Testing; Time; Toddler; Training; Transfusion; Umbilical cord structure; Urine; Washington; Work; autism spectrum disorder; cerebral oxygenation; cost; design; disability; epidemiology study; fetal blood; improved; intervention cost; mortality; multiorgan damage; neonatal hypoxic-ischemic brain injury; neonatal morbidity; neonatal outcome; neonatal resuscitation; neonatal stroke; neurodevelopment; novel; prenatal; pressure; prevent; social; social skills; standard of care; tool; treatment effect

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.

项目概要 我们提出一项研究，看看对那些需要复苏的婴儿进行脐带挤奶 (UCM) 是否有效 比出生时立即夹住并剪断脐带要好。我们想知道它是否会减少死亡 和/或进入 NICU。此外，我们相信它可以通过以下方式减少幸存者的发育问题： 两岁了。 婴儿出生时，开始快速呼吸至关重要。婴儿必须从依赖 胎盘第一次使用肺部供氧。全世界每年有近 1000 万婴儿没有 出生时立即呼吸，其中约 600 万婴儿需要复苏。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，夹紧 在婴儿呼吸之前切断脐带会导致心跳减慢并减少血量 每分钟被从心脏抽出。这项研究将测试婴儿是否会从 UCM 中受益。绳索 切割前会快速挤奶四次，不会延误复苏程序。这项研究是 重要的是，因为当需要复苏时，UCM 或延迟脐带夹紧都不起作用。 由于缺乏证据而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表明，需要复苏的婴儿更有可能出现病症 例如脑瘫、自闭症等发育问题。胎儿体内残留有大量的血液 立即钳夹脐带后的胎盘意味着婴儿大脑、肺部和心脏的血液减少， 这可能会导致脑损伤甚至死亡。出生时脐带挤奶可能有助于保护这些婴儿 增加血容量的转移。我们之前的工作表明，与立即夹紧绳索相比， UCM 可以改善心率、血压、减少早期贫血以及增加大脑中的氧气。无害 任何研究都已注意到 UCM 的作用。 我们将采用一种设计，其中每家医院将被随机分配使用直接脐带 对 12 个月内需要复苏的任何婴儿进行钳夹或 UCM。然后网站将更改为 其他方法再延长 12 个月。家长将在产前被告知有关试验的信息并被邀请参加 出生后，如果他们的婴儿符合条件。该试验将涉及 620 名足月新生儿，他们在 8 岁出生时需要进行复苏 (8) 加利福尼亚州圣地亚哥的医院；加利福尼亚州拉米萨；洛马琳达，加利福尼亚州；加利福尼亚州戴维斯华盛顿特区；和加拿大。这 试验将提供证据来促进支持使用 UCM 的指南的改变——一种简单、免费的方法 干预作为需要复苏的足月和近足月新生儿的标准护理。