Profiling micro RNA in newborns with congenital heart disease
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Boston Children's Hospital · NCT06434207
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 1 Day to 7 Days |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06434207 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is novel in the context of congenital heart disease, similar studies in other conditions have shown promise in understanding clotting mechanisms.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Single-ventricle, Thrombosis