Copenhagen Baby Heart
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Echocardiography; Blood analysis from umbilical cord blood; ECG; Measurement of oxygen saturation
Intervention type(s): Other; Other; Other; Other
Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      Blood sample from umbilical cord for DNA extraction and analysis of biomarkers.