Profiling micro RNA in newborns with congenital heart disease
Official title: Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Run by Boston Children's Hospital · NCT06434207 · Data updated 2026-11-12
This study is trying to understand how certain molecules in the blood of newborns with severe congenital heart disease affect their risk of blood clots during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 31, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT06434207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates with a diagnosis of severe congenital heart disease who are undergoing surgery within their first week of life.
✕Probably not a fit
Patients who do not have severe congenital heart disease or are not undergoing surgery in the specified timeframe may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect plasma samples from neonates diagnosed with severe congenital heart disease (CHD) to investigate the molecular mechanisms behind abnormal clotting profiles that may lead to thrombosis. By analyzing extracellular vesicle micro RNA, the study seeks to enhance understanding of the clotting risks these infants face during the perioperative period. The research will focus on a small cohort of ten neonates at Boston Children's Hospital, providing insights into the fetal-maternal regulation of clotting in this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of clotting risks in newborns with congenital heart disease.
How similar studies have gone: While this approach is novel in the context of congenital heart disease, similar studies in other conditions have shown promise in understanding clotting mechanisms.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life Exclusion Criteria: * None
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Rachel Bernier, MPH
- Email: rachel.bernier@childrens.harvard.edu
- Phone: 857-218-5348
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.