Premature Infants Receiving Cord Milking Or Delayed Cord Clamping

接受脐带挤奶或延迟断脐的早产儿

• 批准号: 9310473
• 负责人: Anup C Katheria
• 金额: $ 63.43万
• 依托单位: SHARP MEMORIAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9310473
• 关键词: Adverse effects; Age; American College of Obstetricians and Gynecologists; Area; Autologous Blood Transfusion; Bilirubin; Birth; Blood; Blood Transfusion; Blood Volume; Blood flow; Brain; Budgets; Cardiac; Cesarean section; Cessation of life; Closure by clamp; Critical Illness; Data; Guidelines; Hemorrhage; Hospitalization; Hour; Human; Hypotension; Incidence; Infant; International; Intervention; Life; Meta-Analysis; Methods; Milk; Morbidity - disease rate; Neonatal; Neurodevelopmental Impairment; Newborn Infant; Operative Surgical Procedures; Organ; Outcome; Perfusion; Phase; Physiological; Placenta; Polycythemia; Premature Infant; Preterm brain injury; Public Health; Randomized; Reporting; Research; Resuscitation; Risk; Safety; Sample Size; Sampling; Solid; Techniques; Testing; Time; Transfusion; Translating; Umbilical cord structure; Vaginal delivery procedure; blood perfusion; cerebral hemodynamics; cerebral oxygenation; cost; design; expectation; follow-up; grasp; improved; intraventricular hemorrhage; neonatal outcome; pilot trial; preterm newborn; trial comparing; trial design

BACKGROUND: Preterm brain injury from intraventricular hemorrhage (IVH) is a pressing worldwide public health problem. Over 12,000 premature newborns develop IVH every year in the US alone. Delaying clamping the umbilical cord at birth for 30-60 seconds provides the newborn with a significant autologous transfusion of blood from the placenta and has been shown to reduce IVH. Delayed cord clamping (DCC) has been shown to reduce overall IVH (mainly lower grades 1 and 2) by 50 percent, but has not reduced the incidence of severe IVH or death. This may reflect inadequate placental transfusion for newborns delivered by Cesarean section (C/S), the most common mode of delivery for very preterm infants. In 3 DCC trials an increased placental transfusion was evident in infants born by vaginal delivery (V/D), but no or minimal transfusion in infants delivered by C/S. We evaluated a technique – umbilical cord milking (UCM) – which provides a placental transfusion by grasping the unclamped umbilical cord and pushing blood towards the newborn several times before the cord is clamped. Our Phase 1 pilot trial (PREMOD) compared UCM to DCC in premature newborns delivered by C/S and V/D. Results were equivalent for V/D. UCM improved blood flow and organ perfusion in C/S infants. SPECIFIC AIMS: The specific aims of this trial are: Aim 1. To compare the incidence of severe IVH and/or death in premature newborns <32 weeks GA delivered by C/S receiving UCM to those receiving DCC. Aim 2. To compare the safety and efficacy profiles of premature newborns <32 weeks GA delivered by C/S receiving UCM vs. DCC during their hospitalization and at 24 months corrected age. Aim 3. To compare the outcomes of premature newborns <32 weeks GA delivered by C/S (from Aims 1 and 2) with those born by V/D receiving UCM or DCC. DESIGN: This trial has a 2-tiered approach that will first demonstrate that the incidence of severe IVH and/or death in premature newborns <32 weeks delivered by C/S with UCM is equivalent to DCC (non-inferiority), and then test whether there is a decreased incidence of severe IVH and/or death with UCM (superiority). This approach is being used in other neonatal trials, is endorsed by the FDA, and can be done within the scope and sample of the proposed trial. DCC: The obstetrician will wait at least 60 seconds to clamp the cord. UCM: The obstetrician will milk about 20 cm of umbilical cord four times over 2 seconds each. Brain oxygenation will be recorded for the first 72 hours of life. Outcomes will include resuscitation interventions and neurodevelopmental follow-up at 2 years. UCM is simple and allows resuscitation of the most critical infants without delay, which justifies its use, even if UCM is equivalent to DCC. Optimal umbilical cord management in premature newborns is an area that urgently needs scientific evidence to establish clear guidelines worldwide.

背景：脑室内出血（IVH）引起的早产儿脑损伤是一个紧迫的全球公众问题， 健康问题。仅在美国，每年就有超过12，000名早产儿发生IVH。延迟箝位 出生时脐带30-60秒为新生儿提供了显著的自体输血， 胎盘的血液，并已被证明可以减少IVH。延迟脊髓夹持（DCC）已被证明 将总体IVH（主要是1级和2级以下）减少50%，但没有减少严重IVH的发生率。 IVH或死亡。这可能反映了剖宫产新生儿胎盘输血不足 （C/S），这是极早产儿最常见的分娩方式。在3项DCC试验中， 输血在阴道分娩（V/D）的婴儿中很明显，但在分娩的婴儿中没有或很少输血 C/S。我们评估了一种技术-脐带挤奶（UCM）-提供胎盘输血， 抓住未夹紧的脐带，在脐带被剪断之前将血液推向新生儿几次。 夹紧。我们的1期先导试验（PREMOD）比较了UCM和DCC在C/S分娩的早产儿中的作用 V/D。V/D的结果等同。UCM改善C/S婴儿的血流和器官灌注。 具体目的：本试验的具体目的是： 目标1。比较GA分娩<32周早产儿严重IVH和/或死亡的发生率 通过C/S接收UCM到那些接收DCC。 目标2.比较C/S分娩<32周GA早产儿的安全性和有效性 在住院期间和24个月矫正年龄时接受UCM与DCC。 目标3.比较通过C/S分娩的<32周GA早产儿的结局（来自目标1和2） 出生于V/D的人接受UCM或DCC。 设计：本试验采用两层方法，首先证明严重IVH和/或 C/S联合UCM分娩的<32周早产儿的死亡率与DCC相当（非劣效性）， 然后检验UCM是否降低了严重IVH和/或死亡的发生率（优效性）。这 这种方法正在其他新生儿试验中使用，得到了FDA的认可，可以在范围内完成， 拟议试验的样本。DCC：产科医生至少要等60秒才能夹住脐带。UCM：The 产科医生将在2秒内抽取约20厘米的脐带四次。大脑氧合会 出生后72小时内的记录。结果将包括复苏干预和神经发育 随访2年。UCM是简单的，并允许复苏的最关键的婴儿没有延误， 即使UCM等同于DCC，也证明其使用是合理的。早产儿的最佳脐带管理 这是一个迫切需要科学证据来在全球范围内建立明确指导方针的领域。