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

Recruiting

• Conditions: Single-ventricle; Thrombosis; Congenital Heart Disease
• Interventions: Other: Collecting discarded blood samples

• Registration Number: NCT06434207
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29
• Study Start: 2024-10-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates with Congenital Heart Disease	Collecting discarded blood samples	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.

Primary Outcome Measures

Name	Time	Method
Characterization of microRNA in whole blood samples from neonates	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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States