Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

项目摘要 每年约有32,000名婴儿患先天性心脏病。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病，其中约38人患有先天性心脏病 这些人中有1%的人将接受一次或多次手术。这群接受心脏手术的婴儿 根据NIH和FDA的定义，代表孤儿疾病人群。在过去的20年里，不断增加 接受体外循环矫治先天性心脏病和/或 单脑室解剖的姑息性手术。这些外科手术已经取得了技术上的进步。 然而，在婴儿的药物管理方面，进展有限。 术后一段时间。最近三碘甲腺原氨酸在婴幼儿中的补充 体外循环(TRICC)临床试验证明，三碘甲腺原氨酸与三碘甲腺原氨酸联合应用 (利塞罗宁)大大减少了心肺手术后呼吸机的使用时间 绕过5个月以下的婴儿。在这个第三阶段的试验中，我们将通过执行 随机安慰剂对照试验研究三碘甲腺原氨酸与三碘甲腺原氨酸(利硫罗宁)的联合应用 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.