Trials / Completed
CompletedNCT02766998
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 0 Days – 1 Day
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Preserved umbilical vein as shunt/conduit | All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit. |
Timeline
- Start date
- 2016-05-16
- Primary completion
- 2021-11-15
- Completion
- 2021-11-15
- First posted
- 2016-05-10
- Last updated
- 2021-11-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02766998. Inclusion in this directory is not an endorsement.