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

NCT06434207 | Recruiting

• 1 other identifier: IRB-P00048093
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Single-ventricle; Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Collecting discarded blood samples

Interventions

Collecting discarded blood samples OTHER

Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Neonates with Congenital Heart Disease

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life.

You may qualify if:

• All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood from neonate

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart; Thrombosis

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases

Central Study Contacts

Rachel Bernier, MPH

CONTACT

857-218-5348; rachel.bernier@childrens.harvard.edu

Hanna Van Pelt, BS

CONTACT

hanna.vanpelt@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 30, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-09

Locations

US (1)