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

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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.'