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 夹紧和切割脐带是对人类的最常见干预措施，发生在1.4亿 年出生。为了最大程度地提高权宜之计（管理第三阶段的人工，开始新生儿复苏），早期绳索 夹紧（ECC）在交付的约30秒内进行。最近，有证据表明健康益处 延迟的绳子夹紧（DCC，夹紧之前等待〜1-2分钟）。在术语新生儿中，多个随机 对照试验（RCT）表明，DCC将血液从胎盘转移到新生儿，导致铁较少 与ECC相比，缺乏贫血和改善神经发育（神经运动）结局。 尽管新生儿的健康优势，但鉴于他们被排除在以前的RCT之外，这是最好的方法 绳索夹在高危妊娠中，尤其是那些因胎儿诊断而复杂的那些 心脏病（CCHD）仍然不确定。尽管人们可能会认为DCC在低风险新的新事物中的好处 天生的人群将仅转化为CCHD新生儿，独特的解剖和生理差异 CCHD的新生儿表明，该亚组中DCC的风险可能与没有CCHD的新生儿的风险有所不同。 因此，在CCHD新生儿出生时出生时最佳的绳索夹紧练习存在治疗困境。这 拟议的研究，标题为“绳索”（先天性心脏病的新生儿中的夹具或延迟）试验 将是第一个确定DCC与ECC在产后和神经发育中的有效性的RCT CCHD新生儿的结果。我们的初步数据表明，在CCHD新生儿中，DCC导致 与ECC相比，全球排名较低的分数（GRS）表明健康结果更好。 GRS是经过验证的复合材料 措施，基于心脏手术后最​​坏的结果或导管插入术，反映了对 PLEX重症监护。鉴于没有高质量数据，也将确定母亲的结局。我们将 利用具有必要基础架构的网站网络，建立的依从率高的指南以及 治疗保真度和跟踪协作记录。目的1是检验以下假设：在CCHD新生儿中， DCC基于较高的Win-ODD （win-ratio适用于包括联系），而不是与ECC。目的2是检验以下假设。 CCHD，DCC将基于双变量的联合测试，在产后22-26mos时导致更好的神经运动结果 结果（对幼儿第二版运动评分和锤子史密斯的发展评估 新生儿神经检查）比ECC。作为次要目标，我们将检验以下假设 CCHD新生儿改善了在3-4mos介导的神经运动谱（一般运动评估）改进 22-26mos的神经运动结果。目的3是精确估计母亲后产后的风险差异 DCC和ECC之间的TUM出血评估生育CCHD新生儿的母亲的安全性。 该审判将推进CCHD新生儿的照顾，并提供国家和国际的证据 统治组织，对弱势人群中的脐带管理产生了全球影响。