Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

项目摘要 每年大约有32，000名婴儿患有先天性心脏病。美国心脏协会 估计有30万21岁以下的儿童患有先天性心脏病， %的人将接受一次或多次外科手术。这组接受心脏手术的婴儿 代表NIH和FDA定义的孤儿疾病人群。在过去的20年里， 许多患者接受了心肺转流术以矫正先天性心脏缺陷和/或 减轻单心室型解剖。这些外科手术已经取得了技术进步。 然而，在药物管理方面的进展有限， 术后时期。三碘甲状腺原氨酸在婴幼儿中的补充 心脏搭桥术（TRICC）临床试验表明，Triostat补充三碘甲状腺原氨酸 （碘甲状腺原氨酸）大大减少了使用心肺功能的外科手术后使用呼吸机的时间 5个月以下的婴儿。在本III期试验中，我们将通过执行以下操作获得确认证据： 随机安慰剂对照试验，检查Triostat（碘甲状腺原氨酸）补充三碘甲状腺原氨酸， 5个月以下的婴儿。

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.