Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

Conditions
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Congenital Heart Defects

Intervention / Treatment
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* Procedure: Preserved umbilical vein as shunt/conduit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preserved umbilical vein<br>Preserved umbilical vein as shunt/conduit | Procedure: Preserved umbilical vein as shunt/conduit<br>* All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from time of insertion to time of Stage II procedure, approximately 6 months |