Actively Recruiting

Age: 1Day - 7Days
All Genders
NCT06434207

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

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 7Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates diagnosed with severe congenital heart disease
  • Scheduled for surgery at Boston Children's Hospital within the first week of life
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

R

Rachel Bernier, MPH

CONTACT

H

Hanna Van Pelt, BS

CONTACT

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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