Actively Recruiting
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Led by Boston Children's Hospital · Updated on 2026-02-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Newborns diagnosed with severe congenital heart disease (CHD) face a higher risk of developing blood clots after cardiac surgery, but the molecular reasons behind this clotting tendency are not well understood. This research aims to study these mechanisms by collecting and analyzing blood samples from neonates with severe CHD during their early life period. The study involves neonates who will undergo corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital. Researchers will collect discarded blood samples from routine clinical lab tests taken before and after surgery to study microRNA profiles related to clotting. During the study, plasma samples will be collected at two timepoints: before and after surgery. Researchers will examine microRNA in whole blood samples two days after collection to better understand clotting processes in these newborns. The study will follow participants from birth through the early postoperative period, with data collected as part of standard care and additional analysis performed on these samples.
CONDITIONS
Brief Title
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates diagnosed with severe congenital heart disease undergoing heart surgery at Boston Children's Hospital within the first week of life
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 week
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery and hospital stay within the first week of life
Participants undergo cardiac surgery and have blood samples collected as part of routine clinical care.
2 blood sample collections (before and after surgery)
Duration - Up to several weeks post-surgery
Participants are observed after surgery with no additional interventions beyond routine care.
No additional study visits; observation through routine healthcare
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Rachel Bernier, MPH
H
Hanna Van Pelt, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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