## Protocol Section
### Identification Module
**NCT ID:** NCT05838079

**Acronym:** CBHS-I

**Brief Title:** Copenhagen Baby Heart Study - Impact

**Official Title:** Copenhagen Baby Heart Study - Impact

#### Organization Study ID Info
**ID:** H-19038069
#### Organization
**Class:** OTHER
**Full Name:** Rigshospitalet, Denmark
### Status Module
#### Completion Date
**Date:** 2029-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2029-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-11-01

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Study First Submit Date:** 2023-04-20
**Study First Submit QC Date:** 2023-04-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Copenhagen University Hospital at Herlev

**Class:** OTHER

**Name:** Copenhagen University Hospital, Hvidovre

#### Lead Sponsor

**Class:** OTHER

**Name:** Henning Bundgaard

#### Responsible Party

**Investigator Affiliation:** Rigshospitalet, Denmark

**Investigator Full Name:** Henning Bundgaard

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018.

Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy.

The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.

**Detailed Description:** Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018.

Purpose:

1. To assess the prevalence of congenital and inherited heart disease not detected prenatally, and through follow-up asses the consequence of these, e.g., bicuspid aortic valve and septal defects.
2. To assess the prevalence of structural and functional anomalies detected by echocardiography and electrocardiography shortly after birth and, by follow-up examination, assess the consequence of these in early childhood.
3. To establish reference values for echocardiography and ECG for Danish children.
4. To assess the association between high-risk pregnancies and complications during pregnancy (e.g., twin/multiple pregnancy, assisted human reproduction, preeclampsia, and gestational diabetes) and the risk for congenital heart disease in the offspring and early childhood.
5. To assess the association between maternal chronic diseases (e.g., thyroid disorders or pre-existing diabetes) and the risk for congenital heart disease in the offspring and early childhood.
6. To assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including lifestyle, environmental and genetic factors.

Methods The birth cohort of CBH constitute over 25.000 new-borns. At birth an umbilical cord blood sample was taken and immediately analysed for routine biochemical markers, and samples were also stored for possibility of future analyses and DNA sequencing.

All clinical examinations (echocardiography, electrocardiography, and measurement of oxygen saturation) took place within the first 2nd month of life, the vast majority within the 1st month, median age at examination was 11 days (interquartile range 7-15). In addition to this CBH has built a unique and extended database which include information about the maternal and paternal health, the pregnancy and birth.

As part of CBHS-I subgroups of the CBH cohort (e.g., children born to mothers with diabetes or preeclampsia, or children with abnormal findings at baseline examinations in CBH) will be invited for follow-up examinations (echocardiography and electrocardiography). There will also be a new inclusion of new-borns from the same geographical area and Hospitals as in CBH in order to expand some of the sub cohorts, e.g., children born to mothers with diabetes.

### Conditions Module

**Conditions:**

- Congenital Heart Disease

### Design Module

#### Bio Spec

**Description:** Venous and/or umbilical cord blood sample for DNA extraction and analysis of biomarkers

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 35000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** New-borns, within the first 30 days of birth.

**Intervention Names:**

- Other: Clinical examination

**Label:** New-borns (CBHS-I)

#### Arm Group 2

**Description:** Children, 3-13 years of age. The children from the original inclusion in CBH, and those included in CBHS-I.

**Intervention Names:**

- Other: Clinical examination

**Label:** Children (CBH and CBHS-I)

#### Arm Group 3

**Description:** Children and adults, age 1-99 years of age. Some subprojects will invite the family members of the participating child for family examinations.

**Intervention Names:**

- Other: Clinical examination

**Label:** Family members

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Children (CBH and CBHS-I)

- Family members

- New-borns (CBHS-I)

**Description:** Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation

**Name:** Clinical examination

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Prevalence of congenital heart disease

**Time Frame:** 10 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant in CBH or
* Family member of a participant in CBH or
* Born to mothers with pre-existing or gestational diabetes at either Rigshospitalet, Hvidovre Hospital, or Herlev Hospital during the period July 2020 through December 2023.

Exclusion Criteria:

* Faliure of providing concent (parents)

**Maximum Age:** 99 Years

**Minimum Age:** 1 Day

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Participants from CBH and in some cases their family members. New-borns of mothers with pre-existing or gestational diabetes, included during CBHS-I.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** henning.bundgaard@regionh.dk

**Name:** Henning Bundgaard, MD, DMSc

**Phone:** +4535450512

**Role:** CONTACT

**Contact 2:**

**Email:** kasper.karmark.iversen@regionh.dk

**Name:** Kasper Iversen, MD, DMSc

**Phone:** +4538686009

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Copenhagen Ø

**Contacts:**

***Contact 1:***

- **Email:** henningbundgaard@regionh.dk

- **Name:** Henning Bundgaard, MD, DMSc

- **Phone:** +4535450512

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Rigshospitalet Copenhagen University Hospital.

**Status:** RECRUITING

**Zip:** 2100

**Location 2:**

**City:** Herlev

**Contacts:**

***Contact 1:***

- **Email:** kasper.karmark.iversen@regionh.dk

- **Name:** Kasper Iversen, MD, DMSc

- **Phone:** +4538686009

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Herlev and Gentofte Hospital

**Status:** RECRUITING

**Zip:** 2730

**Location 3:**

**City:** Hvidovre

**Contacts:**

***Contact 1:***

- **Email:** ingeborg.christina.roerbye@regionh.dk

- **Name:** Christina Rørbye, MD, PhD, Associate Professor

- **Phone:** +4538625520

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Hvidovre Hospital

**Status:** RECRUITING

**Zip:** 2650

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark

**Name:** Henning Bundgaard, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Department of Cardiology, Herlev Hospital, Denmark.

**Name:** Kasper Iversen, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular 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

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: HIGH

- As Found: Congenital Heart Disease

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000006330

- Term: Heart Defects, Congenital

### Misc Info Module

- Version Holder: 2024-05-24
