Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Absense of primary serious adverse events
研究概览
简要总结
This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All fetal diagnoses of complex congenital heart disease diagnosed by fetal echocardiogram requiring cardiac repair with Blalock-Taussig Shunt or Right Ventricle to Pulmonary Artery conduit will be eligible.
- •This includes all pre-natal diagnoses of any single ventricle circulation physiology (SVP).
- •Subjects being delivered via cesarean section or vaginally at Brigham and Women's Hospital will be considered.
排除标准
- •meconium at delivery
- •symptomatic Group B Streptococcus (GBS) positive mothers
- •mothers with chorioamnionitis
- •Hepatitis B or C positive mothers
- •HIV positive mothers.
- •If unable to collect viable cord on the day of delivery of already enrolled subjects, the subject will be removed from the study on day of birth.
结局指标
主要结局
Absense of primary serious adverse events
时间窗: from time of insertion to time of Stage II procedure, approximately 6 months
Primary SAEs are defined as: * Bleeding from shunt/conduit requiring intervention (either medical or surgical) * Shunt/conduit thrombosis * Shunt/conduit infection with positive culture of preservative solution or positive clinical culture following implantation of umbilical vein * Aneurysm of shunt/conduit
次要结局
未报告次要终点
研究者
David Hoganson
Assistant in Cardiac Surgery
Boston Children's Hospital