## Protocol Section
### Identification Module
**NCT ID:** NCT06434207

**Acronym:** EVmiRNA

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

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

#### Organization Study ID Info
**ID:** IRB-P00048093
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston Children's Hospital

#### Responsible Party

**Investigator Affiliation:** Boston Children's Hospital

**Investigator Full Name:** Juan Ibla

**Investigator Title:** Principal Investigator, MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Congenital Heart Disease

- Single-ventricle

- Thrombosis

### Design Module

#### Bio Spec

**Description:** Whole blood from neonate

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: Collecting discarded blood samples

**Label:** Neonates with Congenital Heart Disease

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neonates with Congenital Heart Disease

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

**Name:** Collecting discarded blood samples

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Characterization of microRNA in whole blood samples from neonates

**Time Frame:** 2 days

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 7 Days

**Minimum Age:** 1 Day

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rachel.bernier@childrens.harvard.edu

**Name:** Rachel Bernier, MPH

**Phone:** 857-218-5348

**Role:** CONTACT

**Contact 2:**

**Email:** hanna.vanpelt@childrens.harvard.edu

**Name:** Hanna Van Pelt, BS

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Boston Children's Hospital

**State:** Massachusetts

**Zip:** 02115

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M16686

- Name: Thrombosis

- Relevance: HIGH

- As Found: Thrombosis

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: HIGH

- As Found: Congenital Heart Disease

- ID: M2100

- Name: Univentricular Heart

- Relevance: HIGH

- As Found: Single Ventricle

- ID: M7784

- Name: Embolism

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: T5247

- Name: Single Ventricular Heart

- Relevance: HIGH

- As Found: Single Ventricle

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000013927

- Term: Thrombosis

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000080039

- Term: Univentricular Heart

### Misc Info Module

- Version Holder: 2024-05-31
