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

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766998
• Other study ID #: IRB-P00021450
• Status: Completed
• Phase: N/A
• Start date: May 16, 2016
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from time of insertion to time of Stage II procedure, approximately 6 months