MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS

新生儿重症监护病房的多中心网络

• 批准号: 3552467
• 负责人: JOSEPH B PHILIPS
• 金额: $ 26.56万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-04-01 至 1991-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3552467
• 关键词: echocardiography; human subject; human therapy evaluation; hypoxia neonatorum; mother /infant health care; neonatal intensive care; newborn human (0-6 weeks); oxygen tension; pathologic arteriovenous shunt; pulmonary hypertension; respiratory disorder chemotherapy; respiratory distress syndrome of newborn

The Division of Perinatal Medicine, Department of Pediatrics, University of Alabama at Birmingham has the patients, professional personnel, and resources to more than meet the minimum and desirable requirements to participate, with NICHD and other major research centers, in a cooperative network of NICUs in order to develop priorities and to plan, implement and analyze a series of multicenter, randomized clinical trials designed to solve major unresolved dilemmas in current neonatal care practices. We also provide evidence of past and present excellence and experience in the planning and performance of clinical trials in newborn patients. We propose the first randomized, controlled trial of therapies in persistent pulmonary hypertension of the newborn (PPHN). At least 5,000 infants have PPHN and at least 1,500 of these die yearly in the U.S. Two therapies, tolazoline infusion and mechanical hyperventilation, have evolved without rigorous proof of efficacy for either. We propose 3 hypotheses: (1) tolazoline is more effective than placebo in raising distal aortic oxygen tension; (2) hyperventilation raises distal aortic oxygen tension in a higher percentage of infants with PPHN than does tolazoline; (3) hyperventilation maintains elevated distal aortic oxygen tension longer than does tolazoline. A multicentered trial is needed because PPHN is too rare to allow timely testing of the hypotheses within one center. Once PPHN is diagnosed, subjects will be randomized to receive either tolazoline or hyperventilation. Tolazoline and placebo will be given in a double blind crossover fashion at 15-minute intervals, and distal aortic oxygenation changes observed in order to test Hypothesis 1. Distal aortic oxygenation changes will also be used to test Hypothesis 2. Responders to a treatment will be maintained on that treatment until it fails or the infant recovers. We propose use of sequential methods to test hypothesis 1 and 2 and survival curve analysis to test Hypothesis 3. Multiple confounding factors complicate the design and execution of a study such as this. Performance of a properly designed study of therapy in PPHN will provide a scientific basis for future studies and improve the outlook for thousands of infants every year.

大学围产期医学系儿科学系 伯明翰的阿拉巴马州有患者，专业人员和 资源不仅满足最低和理想的要求 与NICHD和其他主要研究中心一起参加合作 NICUS网络以制定优先级并计划，实施和 分析一系列旨在的多中心随机临床试验 在当前的新生儿护理实践中解决了主要的未解决困境。 我们 还提供了过去和现在的卓越和当前卓越和经验的证据 新生儿临床试验的计划和性能。 我们提出了第一个在 新生儿（PPHN）的持续性肺动脉高压。 至少5,000 婴儿每年在美国有PPHN，其中至少有1,500人死亡 疗法，甲唑啉输注和机械过度换气，具有 进化而没有严格的疗效证明。 我们提出3 假设：（1）甲唑啉比安慰剂更有效 远端主动脉氧张力； （2）换气过度会增加远端主动脉 PPHN的婴儿比例更高的氧气张力 甲唑啉； （3）换气过度保持较高的远端主动脉氧 张力长于甲唑啉。 需要进行多中心试验 因为PPHN太罕见了，无法及时测试中的假设 一个中心。 一旦诊断出PPHN，受试者将被随机分配 甲唑啉或过度换气。 tolazoline和安慰剂将 以15分钟的间隔以双盲跨界方式给予 为了检验假设1，观察到远端主动脉氧合变化。 远端主动脉氧合变化也将用于检验假设2。 响应者将在该治疗上保持治疗 失败或婴儿恢复。 我们建议使用顺序方法测试 假设1和2和生存曲线分析以检验假设3。 多个混杂因素使研究的设计和执行复杂化 这样的。 在PPHN中进行适当设计的治疗研究 将为将来的研究提供科学基础，并改善前景 每年有成千上万的婴儿。