1/2 CORD-CHD: Clamp OR Delay among neonates with Congenital Heart Disease

1/2 CORD-CHD：先天性心脏病新生儿的钳夹或延迟治疗

• 批准号: 10571076
• 负责人: Carl Backes
• 金额: $ 90.73万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10571076
• 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; 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 in 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 complex inten- sive 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 neuro- motor outcomes at 22-26mos. Aim 3 is to precisely estimate the difference in the risk of maternal postpartum 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 international organizations, creating a global impact on umbilical cord management among a vulnerable population.

项目总结/摘要 夹紧和切断脐带是人类最常见的干预措施，发生在1.4亿人中。 每年出生。为了最大限度地方便（管理第三产程，开始新生儿复苏）， 夹持（ECC）在输送后约30秒内进行。最近，有证据表明， 延迟脐带夹紧（DCC，夹紧前等待约1-2分钟）。在足月新生儿中， 对照试验（RCT）表明，DCC将血液从胎盘转移到新生儿，导致铁减少， 与ECC相比，在4年内，缺乏性贫血和改善神经发育（神经运动）结果。 尽管对健康新生儿有优势，但鉴于他们被排除在先前的RCT之外， 在高危妊娠中进行脐带钳夹，特别是那些胎儿诊断为严重先天性 心脏病（CCHD），仍然不确定。虽然人们可能会认为DCC在低风险新- 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， CCHD的新生儿提示此亚组中DCC的风险可能不同于无CCHD的新生儿。 因此，在CCHD新生儿中，出生时最佳脐带夹紧实践存在治疗困境。的 拟进行的名为CORD-CHD（先天性心脏病新生儿钳夹或延迟）试验的研究将 第一项确定DCC与ECC对出生后和神经发育结局的有效性的RCT CCHD新生儿我们的初步数据表明，在CCHD新生儿中，DCC导致较低的总体 等级评分（GRS），表明比ECC更好的健康结果。GRS是一种经过验证的综合指标， 基于心脏手术或导管插入术后的最差结果，并反映了对复杂的inten的需求， 特殊护理由于缺乏高质量的数据，还将确定产妇的结局。我们将利用 具有必要基础设施的研究中心网络，具有高依从率和治疗的既定指南 忠诚度和合作记录目的1是检验假设，在CCHD新生儿中，DCC 导致较低的GRS（更好的结果）后，心脏手术或导管插入术，基于较高的获胜几率（赢， 比率适合于包括领带），而不是ECC。目的2是检验假设，在新生儿CCHD中， 根据双变量结局的联合检验，DCC将在出生后22- 26个月产生更好的神经运动结局 幼儿发育评估第二版运动评分和哈默史密斯新生儿 神经学检查）而不是ECC。作为次要目的，我们将检验以下假设： 新生儿在3- 4个月时改善神经运动特征（一般运动评估）， 22- 26个月时的运动结局。目的3是精确估计产妇产后风险的差异 DCC和ECC出血之间的差异，以评估分娩CCHD新生儿的母亲的安全性。这 该试验将促进CCHD新生儿的护理，并提供国家和国际要求的证据。 该项目是一个全球性的项目，对弱势群体的脐带管理产生了全球影响。