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.
Conditions
Congenital Heart Defects
Recruitment Status
Completed
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.
Intervention
Intervention Type
Intervention Name
Procedure
Preserved umbilical vein as shunt/conduit
Phase
Not Applicable
Gender
All
Min Age
0 Days
Max Age
1 Day
Download Date
November 23, 2021
Principal Investigator
David Hoganson
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: