Copenhagen Baby Heart Study: a population study of newborns with prenatal inclusion
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Congenital heart diseases (CHDs) are reported in 0.8% of newborns. Numerous factors influence cardiovascular development and CHD prevalence, and possibly also development of cardiovascular disease later in life. However, known factors explain the probable etiology in only a fraction of patients. Past large-scale population-based studies have made invaluable contributions to the understanding of cardiac disease, but none recruited participants prenatally and focused on the neonatal period. The Copenhagen Baby Heart Study (CBHS) is a population-based study of the prevalence, spectrum, and prognosis of structural and functional cardiac abnormalities. The CBHS will also establish normal values for neonatal cardiac parameters and biomarkers, and study prenatal and early childhood factors potentially affecting later cardiovascular disease risk. The CBHS is an ongoing multicenter, prospective study recruiting from second trimester pregnancy (gestational weeks 18–20) (expected n = 25,000). Information on parents, pregnancy, and delivery are collected. After birth, umbilical cord blood is collected for biochemical analysis, DNA purification, and biobank storage. An echocardiographic examination, electrocardiography, and post-ductal pulse oximetry are performed shortly after birth. Infants diagnosed with significant CHD are referred to a specialist or admitted to hospital, depending on CHD severity. CBHS participants will be followed prospectively as part of specific research projects or regular clinical follow-up for CHD. CBHS design and methodology are described. The CBHS aims to identify new mechanisms underlying cardiovascular disease development and new targets for prevention, early detection, and management of CHD and other cardiac diseases presenting at birth or developing later in life.
KeywordsCongenital heart disease Cardiovascular development Cardiovascular disease Risk factors Epidemiology Reference material
The CBHS receives financial support from the Danish Heart Association, the Danish Children’s Heart Foundation, Candy’s Foundation, the Toyota Foundation, the Herlev-Gentofte Hospital Research Foundation, and the Gangsted Foundation. The funders have no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of manuscripts; or in decisions to publish results.
AS wrote the manuscript and participated in the study design and acquisition of data. All authors participated in the study design and acquisition of data. KI and HB had the original idea for the study and wrote the protocol. All authors critically revised the manuscript and approved the final version. AS is the guarantor of the paper.
Compliance with ethical standards
Conflict of interest
The Copenhagen Baby Heart Study receives financial support from the Danish Heart Association, the Danish Children’s Heart Foundation, Candy’s Foundation, the Toyota Foundation, the Herlev-Gentofte Hospital Research Foundation, and the Gangsted Foundation. The funders have no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of manuscripts; or in decisions to publish results. All authors have no other conflicts of interests to declare.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained for all individual participants included in the study.
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