NCT06434207

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease
• Single-ventricle
• Thrombosis

Interventions

Type	Name	Description
OTHER	Collecting discarded blood samples	Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-30
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States