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（由申请人提供）：极早产儿（EPT）的婴儿死亡率是足月出生婴儿的100倍以上，存活下来的婴儿患神经发育障碍的风险很高。这些婴儿具有非常脆弱的脑微血管和不成熟的心血管反射，这使得他们非常容易受到脑损伤，如颅内出血（IVH）或缺血。大部分损伤被认为发生在从子宫内到子宫外生命过渡的几分钟内。在过渡期间协助EPT婴儿的常见协议是产科医生在分娩后立即夹住脐带，以允许产科医生根据需要提供复苏措施。新的证据表明，出生后延迟30秒或更长时间的脐带夹紧（DCC）可能对早产儿有益。尽管如此，大多数产科医生并没有对所有EPT婴儿采用DCC，他们担心其中一些高危婴儿需要呼吸帮助，因此需要迅速剪断脐带，以便婴儿能够接触新生儿科医生。其实大部分 以前的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胎盘上时辅助呼吸比在DCC期间发生的胎盘输血更重要。这项多中心试验将在极早产婴儿中进行比较，包括那些需要复苏的婴儿，延迟脐带夹闭30秒，然后辅助通气（标准队列），延迟脐带夹闭120秒，同时在30和120秒之间辅助通气，脐带完整（研究队列）。如果在脐带夹紧之前辅助呼吸可以改善结局（没有IVH的情况下更好的存活率），这项研究可能会导致新的指导方针，用于立即稳定出生后极早产的婴儿，并随后降低这一非常高风险婴儿群体的死亡率和发病率。