Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT06434207

Conditions

Congenital Heart Disease

Single-ventricle

Thrombosis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Collecting discarded blood samples

Study Details

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

Study ID

NCT06434207

Start date

Oct 31, 2024

Status verified date

Sep, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Collecting discarded blood samples

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

Primary outcome measure

  • Characterization of microRNA in whole blood samples from neonates [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Rachel Bernier, MPH

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

Hanna Van Pelt, BS

hanna.vanpelt@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jocelyn Booth, BSN

857-218-4585jocelyn.booth@childrens.harvard.edu

Rachel Bernier, MPH

18572185348rachel.bernier@childrens.harvard.edu

Principal Investigator:

Koichi Yuki, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Feb 23, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-02-23.