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: 9914830
• 负责人: Anup C Katheria
• 金额: $ 57.25万
• 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/9914830
• 关键词: 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; optimal treatments; pilot trial; preterm newborn; side effect; 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：脑室出血(IVH)所致的早产儿脑损伤是一个紧迫的世界性问题。 健康问题。仅在美国，每年就有超过12000名早产儿患上IVH。延迟夹紧 出生时脐带持续30-60秒为新生儿提供重要的自体输血 来自胎盘的血液，并已被证明可以减少IVH。延迟性脐带夹闭(DCC)已显示 将整体IVH(主要是较低的1级和2级)减少50%，但并未降低重症 IVH或死亡。这可能反映了剖宫产新生儿胎盘输注不足。 (C/S)，极早产儿最常见的分娩方式。在3个DCC试验中，胎盘增加 阴道分娩(V/D)的婴儿输血很明显，但分娩的婴儿不输血或输血很少 我们评估了一种技术--脐带挤奶(UCM)--它通过以下方式提供胎盘输血 抓住未夹住的脐带，并在脐带停止之前多次将血液推向新生儿 被夹住了。我们的第一阶段试点试验(PREMOD)在C/S分娩的早产儿中比较了UCM和DCC 和V/D的结果相当于V/D。UCM改善了C/S婴儿的血流和器官灌注量。 具体目标：本次试验的具体目标是： 目的1.比较早产儿严重IVH和/或死亡的发生率及胎龄32周 由承兑汇票的S承兑UCM至承兑承兑汇票的承兑汇票。 目的2.比较C/S分娩早产儿&32周胎龄的安全性和有效性 在他们住院期间和在校正年龄24个月时接受UCM和DCC。 目的3.比较C/S(目标1和目标2)分娩的早产儿和早产儿32周的结局 V/D出生的人接受UCM或DCC。 设计：这项试验采用两级方法，首先将证明严重静脉内出血和/或 C/S胎心早产儿32周死亡相当于DCC(非劣势) 然后测试UCM是否降低了严重IVH和/或死亡的发生率(优势)。这 该方法正在其他新生儿试验中使用，得到FDA的认可，可以在范围内和 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 产科医生将为大约20厘米的脐带挤奶四次，每次2秒。脑氧合作用将是 在生命的前72小时被记录下来。结果将包括复苏干预和神经发育 随访2年。UCM很简单，可以立即复苏最危急的婴儿，这 即使UCM等同于DCC，它的使用也是合理的。早产儿的最佳脐带管理 这是一个迫切需要科学证据的领域，以便在全球范围内建立明确的指导方针。