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: 10401868
• 负责人: Anup C Katheria
• 金额: $ 59.09万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10401868
• 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.

项目摘要 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 比一出生就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/或进入新生儿重症监护室此外，我们相信它可以减少幸存者的发育问题， 两岁。 出生时，婴儿开始快速呼吸是至关重要的。婴儿必须从依赖 从胎盘供氧到第一次用肺呼吸全世界每年有近一千万婴儿 出生时立即呼吸，其中约有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， 脐带在婴儿呼吸前会导致心跳减慢， 每分钟从心脏泵出的血液这项研究将测试婴儿是否会受益于UCM。脐带 在切割前将快速挤奶四次，不会延误复苏程序。本研究 这一点很重要，因为当需要复苏时，无论是UCM还是延迟脐带夹闭， 由于缺乏证据，国家和国际组织建议。然而，一些大型研究 来自世界各地的研究发现，需要复苏的婴儿更有可能出现疾病 例如大脑性麻痹、自闭症和其他发育问题。大量的胎儿血液留在 脐带立即夹紧后的胎盘意味着婴儿获得的大脑，肺和心脏的血液减少， 会导致脑损伤甚至死亡出生时用脐带挤奶可能有助于保护这些婴儿， 增加了血量的转移。我们先前的工作表明，与立即夹紧脐带相比， UCM导致更好的心率，血压，更少的早期贫血和更多的大脑氧气。没有伤害 在任何研究中都注意到了UCM。 我们将采用一种设计，每家医院将被随机分配使用任何一种直接脐带 钳夹或UCM用于任何需要复苏的婴儿超过12个月。然后，网站将更改为 另一种方法是12个月。父母将被告知有关试验产前和邀请参加 如果他们的婴儿符合条件的话。这项试验将涉及620名在出生时需要复苏的足月新生儿， (8)位于加利福尼亚州圣地亚哥、加利福尼亚州拉梅萨、加利福尼亚州洛马琳达、加利福尼亚州戴维斯、华盛顿和加拿大的医院。这 试验将提供证据，以促进改变指导方针，支持使用UCM -一个简单的，免费的， 干预作为需要复苏的足月和近足月新生儿的标准护理。

项目成果

Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial.

无活力新生儿脐带挤奶的血流动力学变化：随机集群交叉试验。

• DOI: 10.1016/j.jpeds.2023.03.001
• 发表时间: 2023
• 期刊: The Journal of pediatrics
• 作者: Katheria,Anup;Mercer,Judith;Poeltler,Deb;Morales,Ana;Torres,Nohemi;Lakshminrusimha,Satyan;Singh,Yogen
• 通讯作者: Singh,Yogen

Cardiac and cerebral hemodynamics with umbilical cord milking compared with early cord clamping: A randomized cluster crossover trial.

脐带挤奶与早期脐带夹闭相比的心脑血流动力学：一项随机集群交叉试验。

• DOI: 10.1016/j.earlhumdev.2023.105728
• 发表时间: 2023
• 期刊: Early human development
• 影响因子: 2.5
• 作者: Katheria,AnupC;Law,BrendaHiuYan;Poeltler,Debra;Rich,Wade;Ines,Felix;Schmölzer,GeorgM;Lakshminrusimha,Satyan
• 通讯作者: Lakshminrusimha,Satyan

Parental Perspectives on a Trial Using Waived Informed Consent at Birth.

父母对使用出生时放弃知情同意的试验的看法。

• DOI: 10.21203/rs.3.rs-3487820/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Katheria,Anup;Schmolzer,Georg;Law,Brenda;Yoder,Bradley;Clark,Erin;El-Naggar,Walid;Morales,Ana;Dorner,Rebecca;Mooso,Benjamin;Rich,Wade;Vora,Farha;Finer,Neiil
• 通讯作者: Finer,Neiil

Application of desirability of outcome ranking to the milking in non-vigorous infants trial.

结果排名的合意性在非活力婴儿挤奶试验中的应用。

• DOI: 10.1016/j.earlhumdev.2023.105928
• 发表时间: 2024
• 期刊: Early human development
• 影响因子: 2.5
• 作者: Katheria,AnupC;ElGhormli,Laure;Rice,MadelineM;Dorner,RebeccaA;Grobman,WilliamA;Evans,ScottR
• 通讯作者: Evans,ScottR