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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.
Boston Children's Hospital
Boston, Massachusetts, United States
Absense of primary serious adverse events
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
Time frame: from time of insertion to time of Stage II procedure, approximately 6 months
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