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

NCT02766998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-11-23

No results posted yet for this study

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

  • Congenital Heart Defects

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sitaram Emani, MD · Cardiovascular Surgeon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2021-11-15
Completion
2021-11-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766998 on ClinicalTrials.gov