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

Last updated: November 15, 2021
Sponsor: Boston Children's Hospital
Overall Status: Completed

Phase

N/A

Condition

Pentalogy Of Cantrell

Treatment

N/A

Clinical Study ID

NCT02766998
IRB-P00021450
  • Ages < 1
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All fetal diagnoses of complex congenital heart disease diagnosed by fetalechocardiogram requiring cardiac repair with Blalock-Taussig Shunt or Right Ventricleto 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'sHospital will be considered.

Exclusion

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.

Study Design

Total Participants: 2
Study Start date:
May 16, 2016
Estimated Completion Date:
November 15, 2021

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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