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）和神经损伤之间存在联系。这可能是由于缺氧输送到大脑。不幸的是，目前还没有一种治疗方法能有效地预防早产儿脑部血流量过低。改善血液流动的一种可能的方法是，在婴儿出生后，通过延迟脐带的夹紧，让早产儿被动地从脐带和胎盘中接受更多的血液。然而，对于极度早产或生病的婴儿，通常不会延迟夹紧脐带，因为这会推迟他们最初的稳定，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，同时最大限度地减少治疗延误的方法。早产儿脐带挤奶已被证明可以改善血压，减少输血的需要，并增加生命最初几天的尿量。目前还不清楚脐带挤奶是否能促进大脑的血液流动。具体目的：本研究有两个目的：1)评估脐带挤奶（UCM）与脐带立即夹紧（ICC）对早产儿（妊娠<32周）血液动力学的影响；2)评估和比较脐带挤奶和脐带立即夹紧（ICC）在住院期间的临床结果。设计：本研究是一项随机、部分盲法对照临床试验，旨在评估接受UCM或ICC治疗的早产儿的全身血流量。如前所述，UCM将通过抓住脐带并连续三次向婴儿挤约20厘米的脐带来进行。将在6、18和30小时进行连续心脏超声检查。主要结局指标将是上腔静脉（SVC）流量，这是一种全身血流量指标。临床结果将包括复苏干预、脑组织饱和度（StO2）、分数氧提取（FOE）、血压、生命最初2天的尿量、IVH发生率和接受输血次数。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对早产儿重要血流量指标影响的随机研究。增加的血流量可以减少脑出血的发生率和随后的发育问题，非常早产儿。

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.