Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

描述（由申请人提供）： 在过去的20年里，越来越多的患者接受了心肺转流术，以矫正先天性心脏病和/或缓解单心室型解剖结构。虽然这些外科手术已经取得了技术进步，但在术后期间婴儿的药物管理方面进展有限。尽管许多中心已在较大婴儿和儿童中应用了快速拔管策略，但新生儿和幼儿术后仍表现出发病率，通常导致机械通气时间延长。 申请方报告称，最近在接受心肺转流术的婴儿和儿童中补充三碘甲状腺原氨酸（TRICC）的临床试验证明，在5个月以下的婴儿中，使用Triostat（碘甲状腺原氨酸）补充三碘甲状腺原氨酸可减少使用心肺转流术的外科手术后使用呼吸机的时间。 但是，研究设计未按照美国食品药品监督管理局（FDA）要求的格式提供该药物标签上适应症变更的数据。 为了申请三碘甲腺原氨酸（碘甲腺原氨酸）的标签变更并显著影响当前的治疗标准，研究者旨在前瞻性研究特定年龄组。 在拟议的研究中，三碘甲状腺原氨酸补充后，心肺转流（CPB）在婴儿改善临床结果的假设将进行测试。 这项III期、随机、双盲、安慰剂对照试验旨在获得TRICC试验的结果，即在5个月以下婴儿中补充Triostat（碘甲状腺原氨酸）可减少心肺转流手术后使用呼吸机的时间，并证实在心肺转流手术后补充三碘甲状腺原氨酸在该年龄组中是安全的。

DESCRIPTION (provided by applicant): 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. While technical advances have been made in these surgical procedures, progress has been limited with regard to pharmacologic management of infants during the postoperative period. Although rapid extubation strategies have been applied at many centers in older infants and children, neonates and young infants still demonstrate morbidity after surgery, often resulting in prolonged time on mechanical ventilation. It was reported by the applicant that the recent Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) clinical trial demonstrated that triiodothyronine supplementation with Triostat (liothyronine) reduced time on the ventilator after surgical procedures using cardiopulmonary bypass in infants under 5 months of age. However, the study design did not provide data in the format required by the Food and Drug Administration (FDA) for an indication change on the label for this drug. To apply for the labeling change for triiodothyronine (liothyronine) and significantly impact the current standard of care, the investigators aim to prospectively study the specific age groups. In the proposed study the hypothesis that triiodothyronine supplementation after cardiopulmonary bypass (CPB) in infants improves clinical outcome will be tested. This Phase 3, randomized, double-blind, placebo-controlled trial aims to obtain results confirming those of the TRICC trial that triiodothyronine supplementation with Triostat (liothyronine) in infants under 5 months of age reduces time on the ventilator after surgical procedures using cardiopulmonary bypass and confirming that triiodothyronine supplementation is safe in this age group after cardiopulmonary bypass.