Congenital Heart Defects
Conditions
Brief summary
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.
Interventions
PROCEDUREPreserved umbilical vein as shunt/conduit
All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absense of primary serious adverse events | 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 |
Countries
United States
Outcome results
None listed