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

描述(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问题，如脑瘫。脑低血流量与脑室出血(IVH)和神经损伤的发展之间存在联系。这可能是由于缺乏输送到大脑的氧气。不幸的是，没有任何治疗方法被证明能有效防止早产儿脑内低血流量。一种可能的改善血流的方法是允许早产儿在婴儿出生后通过推迟夹住脐带来被动地从脐带和胎盘接收更多的血液。然而，延迟夹住脐带通常不会在极早产或患病的婴儿身上进行，因为这会推迟他们最初的稳定，并导致新生儿体温过低。给早产儿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式，同时将治疗延误降至最低。早产儿的脐带挤奶已被证明可以改善血压，减少输血需求，并增加出生后最初几天的尿量。目前尚不清楚脐带挤奶是否会增加流向大脑的血液。具体目的：本研究有两个目的：1)比较早产儿脐带挤奶(UCM)和即刻脐带夹闭(ICC)对血流动力学的影响；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：这项研究是一项随机、部分盲法对照的临床试验，旨在评估接受UCM或ICC治疗的早产儿的全身血流。如前所述，UCM将通过抓住脐带并向婴儿连续挤奶约20厘米的脐带连续三次进行。连续心脏超声检查将在出生后6、18和30小时进行。主要的预后指标将是上腔静脉(SVC)血流，这是全身血流的一个指标。临床结果将包括复苏干预、脑组织饱和度(StO2)、吸氧分数(FOE)、出生后头两天的血压和尿量、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个月生命中的血红蛋白水平。这将是第一项观察UCM对极早产儿重要血流指标影响的随机研究。增加血流量可能会减少极早产儿脑出血和随后的发育问题的发生率。

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.