RIGHT VENTR V MOD BLALOCK-TAUSSIG SHUNT IN INFANTS WITH SINGLE VENTRICLE DEFECT

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 这是一项多中心、随机对照的临床试验。研究参与者将是出生时左心室发育不良并在新生儿期接受诺伍德手术的儿童。诺伍德手术包括放置分流器以提供肺血流。有两种方法提供肺血流量。标准技术，Blalock Tausig分流术（BTS）包括从主动脉的分支到肺动脉的分流术。从右心室到肺动脉分支的分流术是一种较新的方法。受试者将被随机分配至经典Blalock Tausig分流术组或右心室至肺动脉分流术组（从右心室至肺动脉）。患者将作为新生儿入组。入组资格将不涉及种族或性别以任何方式。 手术后，将对参与者进行一系列结局测量：将仔细监测ICU病房的病程以及总体发病率和死亡率。额外的测试将包括少量的血液测试，口腔涂片测试，以评估特定的遗传多态性，完成问卷调查和神经发育测试。记录将提供给研究受试者，但保密。数据的硬拷贝将保存在锁定的空间中。本研究的电子信息将保存在锁定数据库中。数据中心将设在新英格兰研究所。将获得书面知情同意书。'

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multi-center, randomized controlled clinical trial. Study participants will be children born with hypoplastic left ventricle and undergoing a Norwood operation during the newborn period. The Norwood operation includes placement of a shunt to provide pulmonary blood flow. There are two methods to provide pulmonary blood flow. The standard technique, a Blalock Tausig shunt (BTS) includes placement of a shunt from a branch of the aorta to the pulmonary arteries. A shunt from the right ventricle to the branch pulmonary arteries is a newer method. Participants will be randomized to either a clasic Blalock Tausig shunt or to a right ventricle to pulmonary artery shunt positioned from the rt. ventricle to the pulmonary arteries. Patients will be enrolled as newborns. Eligibility for enrollment will not involve race or gender in any way. Following surgery participants will be followed for a number of outcome measurements: The course in the ICU unit will be carefully monitored, as well overall morbidity and mortality. Additional tests will include a small amount of blood testing, buccal smear testing to evaluate for a specific genetic polmorphism, completion of questionnaires, and neurodevelopmental testing. Records will be linkable to study subjects but kept confidential. Hard copies of data will be kept in a locked space. Electronic information for this study will kept in a locked database. The data center will be at the New England Research Institute. Written informed consent will be obtained.'