Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Defects
• Interventions: Procedure: Preserved umbilical vein as shunt/conduit

• Registration Number: NCT02766998
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-10
• Study Start: 2016-05-16
• Status Verified: 2021-11
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preserved umbilical vein	Preserved umbilical vein as shunt/conduit	Preserved umbilical vein as shunt/conduit

Primary Outcome Measures

Name	Time	Method
Absense of primary serious adverse events	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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States