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

Boston Children's Hospital

Status: Enrolling

Conditions: Thrombosis; Single-ventricle; Congenital Heart Disease

Treatments: Other: Collecting discarded blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT06434207

IRB-P00048093

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Neonates with Congenital Heart Disease

Description:

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.

Treatment:

Other: Collecting discarded blood samples