Current Environment:

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

Minimum Age

N/A

Maximum 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: