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NCT06434207 Clinical Trial

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

Congenital Heart Disease Clinical Trial

— EVmiRNA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06434207
Other study ID # IRB-P00048093
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information
Verified date May 2024
Source Boston Children's Hospital
Contact Rachel Bernier, MPH
Phone 857-218-5348
Email rachel.bernier@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date June 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 7 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Collecting discarded blood samples
Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of microRNA in whole blood samples from neonates 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 2 days
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