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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06434207
Acronym
EVmiRNA
Enrollment
10
Registered
2024-05-30
Start date
2024-10-31
Completion date
2026-12-01
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Single-ventricle, Thrombosis

Brief summary

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.

Interventions

Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of microRNA in whole blood samples from neonates2 daysisolation, 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

Countries

United States

Contacts

CONTACTRachel Bernier, MPH
rachel.bernier@childrens.harvard.edu857-218-5348
CONTACTHanna Van Pelt, BS
hanna.vanpelt@childrens.harvard.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026