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Completed

NCT Number: NCT02753348

Copenhagen Baby Heart

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at one of three hospitals in the Copenhagen area

Exclusion criteria

  • Failure of providing consent (parents)

Treatment and study plan

echocardiography

Other

Blood analysis from umbilical cord blood

Other

ECG

Other

Measurement of oxygen saturation

Other

Primary outcomes

  1. Prevalence of congenital heart defects

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Henning Bundgaard

Other

Collaborators

  • Copenhagen University Hospital at Herlev
  • Copenhagen University Hospital, Hvidovre

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2016
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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