Evaluation of Umbilical Cord Milking on Systemic Blood Flow in Premature Infants

描述（由申请人提供）：早产儿有脑出血的风险，这通常会导致发育迟缓或其他神经系统问题，如脑瘫。脑血流量低与脑室内出血（IVH）和神经损伤的发生之间存在联系。这可能是由于缺乏氧气输送到大脑。不幸的是，没有任何治疗方法可以有效地预防早产儿大脑的低血流量。改善血流的一种可能的方法是通过在婴儿出生后延迟脐带的夹紧来允许早产儿被动地从脐带和胎盘接收更多的血液。然而，延迟夹紧脐带通常不会在极早产或患病的婴儿中进行，因为它推迟了他们的初始稳定并导致新生儿体温过低。挤奶或剥离脐带是另一种积极为早产儿提供更多血液的方法，同时最大限度地减少治疗延误。早产儿脐带挤奶已被证明可以改善血压，减少输血的需要，并增加出生后最初几天的尿量。脐带挤奶是否能增加流向大脑的血液还不清楚。具体目标：本研究有两个目的：1）评价脐带挤奶（UCM）与立即脐带夹紧（ICC）对早产儿（<32周妊娠）血流动力学的影响; 2）评估和比较住院期间接受UCM和ICC的婴儿的临床结局。设计图：本研究是一项随机、部分盲法对照临床试验，旨在评价接受UCM或ICC的早产儿的全身血流。如前所述，将通过抓住脐带并连续三次向婴儿挤出约20 cm的脐带进行UCM。将在出生后6、18和30小时进行连续心脏超声检查。主要的结果测量将是上级腔静脉（SVC）流量，这是全身血流的指标。临床结局将包括复苏干预、脑组织饱和度（StO 2）、氧提取分数（FOE）、血压和出生后前2天的尿量、IVH发生率和输血次数。实验室研究将包括出生时、12小时和1个月时的血红蛋白水平。这将是第一个观察UCM对极早产儿血流重要指标影响的随机研究。增加血流量可能会降低极早产儿脑出血和随后发育问题的发生率。

DESCRIPTION (provided by applicant): Premature babies are at risk for bleeding in their brain, which often results in developmental delays or other neurological problems such as cerebral palsy. There is a link between low blood flow to the brain and the development of intraventricular hemorrhage (IVH) and neurological injury. This could be due to the lack of oxygen delivered to the brain. Unfortunately, no therapy has been shown to be effective in preventing low blood flow to the brain in premature babies. One possible way of improving blood flow is to allow premature infants to passively receive more blood from the umbilical cord and placenta by delaying the clamping of the umbilical cord after the infant is born. However, a delayed clamping of the umbilical cord is not usually done in extremely premature or sick babies, because it postpones their initial stabilization and contributes to neonatal hypothermia. Milking, or stripping, the umbilical cord is another way to actively give premature babies more blood while minimizing delays in treatment. Umbilical cord milking in preterm infants has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life. Whether umbilical cord milking enhances blood flow to the brain is not yet known. Specific Aims: There are two aims of this study: 1) To evaluate the hemodynamic effects of umbilical cord milking (UCM) compared to immediate cord clamping (ICC) in premature (<32 weeks gestation) infants 2) To assess and compare the clinical outcomes of infants receiving UCM and ICC during their hospitalization. Design: This study is a randomized partially blinded controlled clinical trial to evaluate systemic blood flow i premature infants receiving UCM or ICC. UCM will be performed by grasping the umbilical cord and milking about 20 cm of cord towards the baby three times in succession, as described previously. Serial heart ultrasounds will be performed at 6, 18 and 30 hours of life. The primary outcome measure will be superior vena cava (SVC) flow, an index of systemic blood flow. Clinical outcomes will include resuscitation interventions, cerebral tissue saturations (StO2), fractional oxygen extraction (FOE), blood pressure, and urine output during the first 2 days of life, incidence of IVH, and number of blood transfusions received. Laboratory studies will include hemoglobin levels at birth, 12 hours and 1 month of life. This will be the first randomized study to look at the effect of UCM on important measures of blood flow in very preterm infants. Increased blood flow may reduce the incidence of brain bleeding and subsequent developmental problems in very premature babies.