Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Boston Children's Hospital
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Characterization of microRNA in whole blood samples from neonates
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 7 Days (Child)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
Neonates with Congenital Heart Disease
Neonates born with severe Congenital Heart Disease undergoing corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital will be eligible for participation. As part of standard clinical care, neonates having cardiac surgery at Boston Children's Hospital have clinical labs drawn during and after surgery. All blood collected from neonates as part of this study will be discarded blood from those routine clinical samples. One sample will be taken before surgery and one sample will be taken after surgery.
Intervention: Collecting discarded blood samples (Other)
Outcomes
Primary Outcomes
Characterization of microRNA in whole blood samples from neonates
Time Frame: 2 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Koichi Yuki
Principal Investigator, MD
Boston Children's Hospital