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体外循环，以纠正先天性心脏缺陷和/或缓解单心室型解剖。虽然在这些外科手术中取得了技术上的进步，但在婴儿术后期间的药物治疗方面进展有限。虽然快速拔管策略已经在许多中心应用于大龄婴儿和儿童，但新生儿和幼儿手术后仍有并发症，经常导致机械通气时间延长。 申请人报告说，最近在婴儿和儿童进行的体外循环(TRICC)临床试验中补充三碘甲腺原氨酸(Liothyronine)表明，在5个月以下的婴儿使用体外循环手术后，补充三碘甲腺原氨酸和三碘甲腺原氨酸(Liothyronine)可以减少使用呼吸机的时间。然而，研究设计没有以食品和药物管理局(FDA)要求的格式提供该药物标签上的适应症更改的数据。为了申请三碘甲腺原氨酸(利托洛宁)的标签变化并显著影响当前的护理标准，研究人员的目标是前瞻性地研究特定的年龄组。在拟议的研究中，将检验婴儿体外循环(CPB)后补充三碘甲腺原氨酸改善临床结果的假设。 这项第三阶段的随机、双盲、安慰剂对照试验旨在获得证实TRICC试验的结果，即在5个月以下的婴儿使用体外循环手术后补充三碘甲腺原氨酸和三碘甲腺原氨酸(Liothyronine)可以减少使用呼吸机的时间，并确认在体外循环后补充三碘甲腺原氨酸在这一年龄组是安全的。

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.