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

Primary Purpose

Congenital Heart Defects

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Preserved umbilical vein as shunt/conduit

About this trial

This is an interventional treatment trial for Congenital Heart Defects

Eligibility Criteria

0 Days - 1 Day (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preserved umbilical vein

Arm Description

Preserved umbilical vein as shunt/conduit

Outcomes

Primary Outcome Measures

Absense of primary serious adverse events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02766998

First Posted

May 2, 2016

Last Updated

November 15, 2021

Sponsor

Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02766998

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 16, 2016 (Actual)

Primary Completion Date

November 15, 2021 (Actual)

Study Completion Date

November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Defects

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preserved umbilical vein

Arm Type

Experimental

Arm Description

Preserved umbilical vein as shunt/conduit

Intervention Type

Procedure

Intervention Name(s)

Preserved umbilical vein as shunt/conduit

Intervention Description

All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.

Primary Outcome Measure Information:

Title

Absense of primary serious adverse events

Description

Time Frame

from time of insertion to time of Stage II procedure, approximately 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Days

Maximum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sitaram Emani, MD

Organizational Affiliation

Cardiovascular Surgeon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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