VentFirst: A multicenter RCT of assisted ventilation during delayed cord clamping for extremely preterm infants

VentFirst：针对极早产儿延迟断脐期间辅助通气的多中心随机对照试验

• 批准号: 9440443
• 负责人: KAREN D FAIRCHILD
• 金额: $ 61.68万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-25 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9440443
• 关键词: Animals; Birth; Blood Circulation; Blood flow; Brain; Brain Hypoxia-Ischemia; Brain Injuries; Brain hemorrhage; Breathing; Cardiovascular system; Cerebrum; Closure by clamp; Cohort Studies; Continuous Positive Airway Pressure; Control Groups; Death Rate; Development; Discipline of obstetrics; Environmental air flow; Gases; Guidelines; Human Resources; Infant; Infant Mortality; Injury; Intermittent Positive-Pressure Ventilation; International; Intervention; Intracranial Hemorrhages; Ischemia; Laboratory Study; Lead; Life; Location; Lung; Measures; Meta-Analysis; Methods; Morbidity - disease rate; Multicenter Trials; Neonatal; Neonatology; Neurodevelopmental Disability; Newborn Infant; Organ; Outcome; Outcome Study; Perinatal; Perinatal mortality demographics; Placenta; Pregnancy; Premature Infant; Procedures; Protocols documentation; Provider; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Reflex action; Research Design; Respiration; Resuscitation; Safety; Solid; Systemic blood pressure; Testing; Time; Transfusion; Umbilical cord structure; United States; base; cerebral microvasculature; cohort; disability; fetal; high risk; high risk population; improved; improved outcome; intraventricular hemorrhage; mortality; neonatal morbidity; neonatal resuscitation; premature; pressure; preterm newborn; programs; public health relevance; vascular bed

 DESCRIPTION (provided by applicant): Infant mortality of babies born extremely preterm (EPT) is more than 100 times that of babies born at term, and those who survive are at high risk of neurodevelopmental disabilities. These babies have very fragile brain microvasculature and immature cardiovascular reflexes, which renders them highly vulnerable to brain injury, such as intracranial hemorrhage (IVH) or ischemia. Much of the injury is believed to occur during the few minutes of transition from intrauterine to extrauterine life. Common protocol for assisting EPT babies during transition is for obstetricians to clamp the umbilical cord immediately following delivery to permit neonatologists to provide resuscitation measures as required. New evidence suggests that delaying cord clamping (DCC) 30 or more seconds after birth may be beneficial for preterm infants. Nevertheless, most obstetricians have not adopted DCC for all EPT babies, with the concern that some of these high-risk babies will need assistance with breathing, thus requiring cutting of the cord quickly to give the babies access to neonatologists. In fact, most of the previous DCC studies have excluded babies who require resuscitation. Animal studies have shown that assisting breathing while the preterm newborn is attached to the placenta is more important than just the placental transfusion that occurs during DCC. This multicenter trial will compare in babies born extremely preterm, including those requiring resuscitation, 30 sec of delayed cord clamping followed by assisted ventilation (the standard cohort), with delayed cord clamping for 120 sec while ventilation is assisted with the cord intact between 30 and 120 sec (the study cohort). If assisting breathing before umbilical cord clamping is shown to result in improved outcomes (better survival without IVH), this study may lead to new guidelines for immediate stabilization of babies born extremely preterm following birth, and subsequently less mortality and morbidity for this very high risk group of babies.

 描述（由适用提供）：出生的婴儿的婴儿死亡率极为早产（EPT）是学期出生的婴儿的100倍以上，而生存的婴儿则具有神经发育障碍的高风险。这些婴儿具有非常脆弱的脑微举行和未成熟的心血管反射，这使它们非常容易受到脑损伤的影响，例如颅内出血（IVH）或缺血。据信，大部分受伤是在从子宫内到外育寿命过渡的几分钟内发生的。过渡过程中协助EPT婴儿的常见协议是使产科医生在分娩后立即固定脐带，以允许新生儿学家根据需要提供复苏措施。新的证据表明，出生后30秒或以上延迟绳索夹紧（DCC）可能对早产儿有益。然而，大多数产科医生尚未为所有EPT婴儿采用DCC，担心其中一些高风险的婴儿需要帮助呼吸方面的帮助，因此需要迅速切割绳索才能使婴儿进入新生儿学家。实际上，大多数 先前的DCC研究排除了需要复苏的婴儿。动物研究表明，在早产新生儿附着在plapeta上时，呼吸比仅仅在DCC期间发生的斑点输血更重要。这项多中心试验将在出生的婴儿中进行比较，包括需要复苏的婴儿，30秒的延迟绳子夹紧，然后进行辅助通风（标准队列），以及延迟的绳索夹紧120秒，而通风在30至120秒之间进行了索的通风完整（研究队列）。如果证明在脐带夹紧之前有助于呼吸会导致预后改善（没有IVH的更好的生存），则这项研究可能会导致新的指南，即在出生后立即稳定出生的婴儿，而生育后出生的婴儿的死亡率和发病率较小，而对这个非常高风险的婴儿的死亡率和发病率较小。