Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Defects
- Sponsor
- Boston Children's Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Absense of primary serious adverse events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
David Hoganson
Assistant in Cardiac Surgery
Boston Children's Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Absense of primary serious adverse events
Time Frame: 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