Copenhagen Baby Heart Study - Impact (CBHS-I)

April 20, 2023 updated by: Henning Bundgaard

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

35000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen Ø, Denmark, 2100
        • Recruiting
        • Rigshospitalet Copenhagen University Hospital.
        • Contact:
      • Herlev, Denmark, 2730
      • Hvidovre, Denmark, 2650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
New-borns (CBHS-I)
New-borns, within the first 30 days of birth.
Other: Clinical examination
Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation
Children (CBH and CBHS-I)
Children, 3-13 years of age. The children from the original inclusion in CBH, and those included in CBHS-I.
Other: Clinical examination
Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation
Family members
Children and adults, age 1-99 years of age. Some subprojects will invite the family members of the participating child for family examinations.
Other: Clinical examination
Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of congenital heart disease
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henning Bundgaard

Collaborators

Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Henning Bundgaard, MD, DMSc, Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark
  • Principal Investigator: Kasper Iversen, MD, DMSc, Department of Cardiology, Herlev Hospital, Denmark.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

July 1, 2029

Study Completion (Anticipated)

July 1, 2029

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19038069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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