Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

心肺绕道术后婴儿的第三阶段三碘甲状腺原氨酸补充

• 批准号: 8610834
• 负责人: Michael A Portman
• 金额: $ 40万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8610834
• 关键词: Phase; Triiodothyronine; Supplementation; Infants; After

Project Summary Congenital heart disease occurs in approximately 32,000 infants per year. The American Heart Association estimates that 300,000 children under age 21 have a congenital heart defect, and approximately thirty-eight percent of these will have one or more surgical procedures. This cohort of infants undergoing cardiac surgery represents an orphan disease population by NIH and FDA definitions. Over the past 20 years increasing numbers of patients have undergone cardiopulmonary bypass for correction of congenital heart defects and or palliation of single ventricle type anatomy. Technical advances have been made in these surgical procedures. However, progress has been limited with regard to pharmacological management of infants during the postoperative period. The recent Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) clinical trial demonstrated that triiodothyronine supplementation with Triostat (liothyronine) dramatically reduced time on the ventilator after surgical procedures using cardiopulmonary bypass infants under 5 months of age. In this Phase III trial we will obtain confirming evidence by performing a randomized placebo controlled trial examining triiodothyronine supplementation with Triostat (liothyronine) in infants under 5 months of age.

项目摘要 每年大约32,000名婴儿发生先天性心脏病。美国心脏协会 据估计，有30万名21岁以下的儿童患有先天性心脏缺陷，大约38岁 其中的百分比将具有一项或多种外科手术。接受心脏手术的婴儿队列 由NIH和FDA定义代表孤儿疾病人群。在过去的20年中 患者的人数经历了心肺旁路，用于纠正先天性心脏缺陷和 /或 单脑室型解剖结构的抑制。这些手术程序已经取得了技术进步。 但是，在婴儿的药理学管理中，进展受到限制 术后期。婴儿和正在接受的儿童的最近补充三碘甲醇 心肺旁路（TRICC）临床试验表明，三碘甲状腺素补充三肠 （liothyronine）在手术后使用心肺后，呼吸机上的时间大大缩短了 绕过5个月以下的婴儿。在此阶段III试验中，我们将通过执行 随机安慰剂对照试验检查三碘甲状腺素补充三肠氨酸（liothyronine） 5个月以下的婴儿。