Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT02766998 |
Recruitment Status :
Completed
First Posted : May 10, 2016
Last Update Posted : November 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Heart Defects | Procedure: Preserved umbilical vein as shunt/conduit | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery |
Actual Study Start Date : | May 16, 2016 |
Actual Primary Completion Date : | November 15, 2021 |
Actual Study Completion Date : | November 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Preserved umbilical vein
Preserved umbilical vein as shunt/conduit
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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. |
- Absense of primary serious adverse events [ Time Frame: from time of insertion to time of Stage II procedure, approximately 6 months ]
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

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Ages Eligible for Study: | 0 Days to 1 Day (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766998
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Sitaram Emani, MD | Cardiovascular Surgeon |
Responsible Party: | David Hoganson, Assistant in Cardiac Surgery, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT02766998 |
Other Study ID Numbers: |
IRB-P00021450 |
First Posted: | May 10, 2016 Key Record Dates |
Last Update Posted: | November 23, 2021 |
Last Verified: | November 2021 |
Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |