Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
NCT ID: NCT06434207
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2024-10-31
2026-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Collecting discarded blood samples
Discarded blood samples will be collected from routine clinical labs collected before and after surgery.
Interventions
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Collecting discarded blood samples
Discarded blood samples will be collected from routine clinical labs collected before and after surgery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
7 Days
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Koichi Yuki
Principal Investigator, MD
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Jocelyn Booth, BSN
Role: primary
Rachel Bernier, MPH
Role: backup
Other Identifiers
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IRB-P00048093
Identifier Type: -
Identifier Source: org_study_id