Copenhagen Baby Heart

October 14, 2020 updated by: Henning Bundgaard

Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018.

Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen saturation and analyses of umbilical cord blood.

The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the yield of routine echocardiography shortly after birth and to establish reference values for echocardiography in Danish neonates.

Prospective follow-up of the birth cohort is planned with the purpose 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 life style, environmental and genetic factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018.

Purpose

  • To assess the prevalence of congenital and inherited heart disease not detected prenatally, e.g. bicuspid aortic valve.
  • To assess the diagnostic and clinical yield of routine echocardiography in neonates.
  • To establish reference values for echocardiography and ECG for Danish neonates.
  • To establish reference values for routine biochemical analyses in umbilical cord blood.
  • To assess the prevalence of familial hypercholesterolemia in Danish newborns.
  • 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 life style, environmental and genetic factors.

Methods Approximately 18.000 children are born yearly in the Copenhagen area. From 1. April 2016 - 1. April 2018 the parents of all newborns will be offered enrollment in the research project when attending a routine prenatal ultrasound.

Investigators plan to enroll >30.000 newborns.

After birth, blood is drawn from the umbilical chord and immediately analyzed for routine biochemical markers. Samples will also be stored for future biochemical analyses and DNA sequencing.

Within the first 14 days of life the children are examined with standardized echocardiography, electrocardiogram and measurements of oxygen saturation.

Information about maternal and paternal health including inherited disorders within the family as well as information about the pregnancy and birth are collected in a central database.

Follow-up When indicated children will be followed clinically. For research-purposes, prospective, register-based follow-up is planned for the entire birth cohort and with clinical visits for sub-groups of the population.

Study Type

Observational

Enrollment (Actual)

25000

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

1 second to 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborns (0-14 days old, or for preterms when >2000g) born at three different hospitals in the Copenhagen area.

Description

Inclusion Criteria:

  • Born at one of three hospitals in the Copenhagen area

Exclusion Criteria:

  • Failure of providing consent (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
Newborns
Newborns (within 14 days from birth)
Other: Echocardiography
Other: Blood analysis from umbilical cord blood
Other: ECG
Other: Measurement of oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of congenital heart defects
Time Frame: 2 years
2 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16001518

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.

Clinical Trials on Congenital Heart Disease

Clinical Trials on Echocardiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe