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: 10681370
• 负责人: ZUBAIR H AGHAI
• 金额: $ 55.74万
• 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/10681370
• 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; Recommendation; 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; neuroprotection; prevent; primary outcome; randomized, clinical trials; 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.

项目总结