Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06434207
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease
  • Single-ventricle
  • Thrombosis

Eligibility Criteria

Sex
ALL
Age
1 Day - 7 Days
Healthy Volunteers
Not accepted

Interventions

  • Collecting discarded blood samples — OTHER
    Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Study Details

Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described. The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.

Key Dates

Start date
Oct 31, 2024
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: Neonates with Congenital Heart Disease
    Neonates born with severe Congenital Heart Disease undergoing corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital will be eligible for participation. As part of standard clinical care, neonates having cardiac surgery at Boston Children's Hospital have clinical labs drawn during and after surgery. All blood collected from neonates as part of this study will be discarded blood from those routine clinical samples. One sample will be taken before surgery and one sample will be taken after surgery.

Primary Outcome Measure

Characterization of microRNA in whole blood samples from neonates [ Time Frame: 2 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Jocelyn Booth, BSN
[email protected]
857-218-4585
Rachel Bernier, MPH
[email protected]
18572185348
Koichi Yuki, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MA

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