Understanding Blood Clot Risk in Newborns with Congenital Heart Disease

This observational study aims to understand why newborns with severe congenital heart disease (CHD) are at higher risk for blood clots after heart surgery. Researchers will collect discarded blood samples from ten neonates (newborns) at Boston Children's Hospital who are undergoing surgery in their first week of life. The goal is to characterize microRNA (tiny molecules that help control gene activity) in these blood samples to learn more about the molecular mechanisms that lead to abnormal clotting. This study is for newborns aged 1 to 7 days with severe CHD who are having surgery, and there are no exclusion criteria. The main goal is to understand the microRNA profile in these blood samples within two days of collection.

Study design
This is an observational study involving 10 neonates. It is not a treatment study but rather focuses on understanding a medical condition.
What's involved
Participation involves collecting discarded blood samples from routine clinical labs before and after surgery. No additional procedures are required.
Compensation
Not stated in the trial record.
Follow-up
MicroRNA will be measured in blood samples at 2 days after collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06434207

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

Recruiting
Not specifiedAges 1–7Observational
Boston Children's Hospital
~10 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Collecting discarded blood samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterization of microRNA in whole blood samples from neonates
Measured over 2 days
Congenital Heart Disease
Single-ventricle
Thrombosis

NCT06434207

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life

Exclusion

None
  • Characterization of microRNA in whole blood samples from neonates2 days

    isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways