2/2 CORD-CHD: Clamp OR Delay among neonates with Congenital Heart Disease

2/2 CORD-CHD：先天性心脏病新生儿的钳夹或延迟治疗

• 批准号: 10570663
• 负责人: Scott Evans
• 金额: $ 78.92万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2030-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10570663
• 关键词: Academy; Age; American; American College of Obstetricians and Gynecologists; Anatomy; Birth; Blood; Cardiac Catheterization Procedures; Cardiac Surgery procedures; Catheterization; Cesarean section; Child; Child Health; Clinical; Closure by clamp; Collaborations; Complement; Complex; Conduct Clinical Trials; Congenital Abnormality; Consent; Critical Care; Data; Data Coordinating Center; Development; Diabetes Mellitus; Enrollment; Environment; Equipoise; Erythrocyte Transfusion; Ethnic Origin; Event; Evidence Based Medicine; Exclusion; Exposure to; Family; Feasibility Studies; Frequencies; Functional disorder; General Population; Gestational Age; Goals; Growth and Development function; Guidelines; Health; Health Benefit; Health Personnel; Heart Abnormalities; Hematology; Hemorrhage; High-Risk Pregnancy; Hospitalization; Hospitals; Human; Hyperviscosity; Infant; Infrastructure; Intensive Care; International; Intervention; Iron deficiency anemia; Joints; Measures; Mediating; Mission; Mothers; Motor; Movement; Neonatal; Neurologic; Neurological outcome; Newborn Infant; Operative Surgical Procedures; Outcome; Parents; Patient-Focused Outcomes; Patients; Pediatrics; Perception; Physiological; Placenta; Polycythemia; Population; Postpartum Hemorrhage; Pregnancy; Process; Public Health; Questionnaires; Race; Randomized; Randomized, Controlled Trials; Recommendation; Records; Reporting; Research Design; Research Personnel; Risk; Safety; Severities; Site; Stroke; Subgroup; Surveys; Survivors; Testing; Thrombosis; Translating; Umbilical cord structure; Uncertainty; United States National Institutes of Health; Vagina; Vulnerable Populations; adherence rate; adverse outcome; body system; clinically significant; cohort; congenital heart disorder; cost; design; effectiveness evaluation; experience; fetal; fetal blood; fetal diagnosis; high risk; improved; maternal hypertension; maternal outcome; maternal risk; mortality; multidisciplinary; myocardial injury; neonatal morbidity; neonatal resuscitation; neonate; postnatal; primary outcome; randomized, clinical trials; recruit; secondary outcome; sex

PROJECT SUMMARY/ABSTRACT Clamping and cutting the umbilical cord is the most common intervention in humans, occurring in 140 million annual births. To maximize expediency (manage 3rd stage of labor, initiate neonatal resuscitation), early cord clamping (ECC) is performed within ~30 sec of delivery. Recently, evidence has emerged on the health benefits of delayed cord clamping (DCC, waiting ~1-2 min before clamping). Among term neonates, multiple randomized controlled trials (RCTs) have shown that DCC transfers blood from placentas to newborns, resulting in less iron- deficiency anemia and improved neurodevelopmental (neuromotor) outcomes through 4 years, than with ECC. Despite advantages for healthy newborns, in view of their exclusion from previous RCTs, the best approach to cord clamping in higher-risk pregnancies, notably those complicated by a fetal diagnosis of critical congenital heart disease (CCHD), remains uncertain. Although one might assume that the benefits of DCC in low-risk new- born populations would translate simply to CCHD neonates, unique anatomic and physiologic differences in neonates with CCHD suggest that risks of DCC in this subgroup may differ from risks in neonates without CCHD. Thus, a treatment dilemma exists on the optimal cord clamping practice at birth among CCHD neonates. The proposed study, entitled CORD-CHD (Clamp OR Delay among neonates with Congenital Heart Disease) trial will be the first RCT to determine the effectiveness of DCC vs. ECC on postnatal and neurodevelopmental outcomes of CCHD neonates. Our preliminary data demonstrate that, among CCHD neonates, DCC results in lower global rank scores (GRS), indicative of better health outcomes, than ECC. GRS is a validated composite measure, based upon the worst outcome post-cardiac surgery or catheterization and reflects the need for com- plex intensive care. Given the absence of high-quality data, maternal outcomes will also be determined. We will leverage a network of sites with requisite infrastructures, established guidelines with high adherence rates and treatment fidelity, and track records of collaboration. Aim 1 is to test the hypothesis that, among CCHD neonates, DCC results in lower GRS (better outcomes) post-cardiac surgery or catheterization, based on a higher win-odds (win-ratio adapted to include ties), than with ECC. Aim 2 is to test the hypothesis that, among neonates with CCHD, DCC will result in better neuromotor outcomes at 22-26mos postnatal, based on a joint test of a bivariate outcome (Developmental Assessment of Young Children Second Edition motor score and the Hammersmith Neonate Neurological Exam) than with ECC. As a secondary objective, we will test the hypothesis that among CCHD neonates improved neuromotor profiles (General Movement Assessment) at 3-4mos mediate improved neuromotor outcomes at 22-26mos. Aim 3 is to precisely estimate the difference in the risk of maternal postpar- tum hemorrhage between DCC and ECC to evaluate safety among mothers who give birth to CCHD neonates. This trial will advance the care of CCHD neonates and provide the evidence called for by national and interna- tional organizations, creating a global impact on umbilical cord management among a vulnerable population.

项目摘要/摘要 夹住和切断脐带是人类最常见的干预措施，发生在1.4亿人中 每年的出生量。为了最大限度地方便(处理第三产程，启动新生儿复苏)，早期脐带 夹紧(ECC)在交付后约30秒内执行。最近，关于健康益处的证据出现了。 延迟夹住脐带(DCC，夹住前等待~1-2分钟)。在足月新生儿中，多项随机 对照试验(RCT)表明，DCC将血液从胎盘转移到新生儿身上，导致更少的铁- 与ECC相比，缺乏性贫血和改善神经发育(神经运动)的结果持续了4年。 尽管对健康的新生儿有好处，但鉴于他们被排除在以前的随机对照试验之外，最好的方法是 脐带夹闭在高危妊娠中的应用，尤其是合并胎儿诊断为危重先天性的妊娠 心脏病(CCHD)，目前仍不确定。尽管有人可能会认为DCC在低风险新的- 出生人口将简单地转化为CCHD新生儿，独特的解剖和生理差异 患有CCHD的新生儿提示，这一亚组中发生DCC的风险可能不同于没有CCHD的新生儿。 因此，在CCHD新生儿出生时最佳的脐带夹持方法存在治疗难题。这个 建议的研究，题为CORD-CHD(先天性心脏病新生儿的钳夹或延迟)试验 将是第一个确定DCC和ECC对出生后和神经发育的有效性的随机对照试验 慢性阻塞性肺疾病新生儿结局。我们的初步数据显示，在CCHD新生儿中，DCC导致 全球排名得分(GRS)比ECC低，这表明健康结果更好。GRS是经过验证的组合 根据心脏手术或导尿术后的最差结果进行衡量，并反映出对... 普莱克斯重症监护室。鉴于缺乏高质量的数据，产妇的结局也将得到确定。我们会 利用站点网络，该网络具有必要的基础设施、高遵从率的既定指导方针以及 治疗的忠诚度，以及合作的记录。第一个目标是检验假设，在CCHD新生儿中， 基于更高的胜算，DCC导致心脏手术或导尿术后较低的GRS(更好的结果) (Win-Ratio调整为包括平局)，而不是与ECC。目标2是检验这一假设，即在患有 基于双变量的联合测试，CCHD，DCC将在出生后22-26个月导致更好的神经运动结果 结果(幼儿发展评估第二版运动评分和Hammersmith 新生儿神经系统检查)，而不是ECC。作为次要目标，我们将测试以下假设 CCHD新生儿3-4个月神经运动评分(一般运动评估)改善 22-26个月的神经运动结果。目标3是精确估计母亲延期风险的差异。 DCC和ECC之间的肠道出血以评估分娩CCHD新生儿的母亲的安全性。 这项试验将推进CCHD新生儿的护理，并提供国家和国际组织要求的证据。 国家组织，对弱势群体的脐带管理产生了全球影响。