Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/1/2019 |
| Start Date: | May 16, 2016 |
| End Date: | January 2022 |
| Contact: | Breanna Piekarski, RN, BSN |
| Email: | breanna.piekarski@cardio.chboston.org |
| Phone: | 617-919-4457 |
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.
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.
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.
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-919-4457
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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