Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
25000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-04-30
Study Completion Date
2018-11-30
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Congenital Heart Disease
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Newborns
Newborns (within 14 days from birth)
Echocardiography
Intervention Type
OTHER
Blood analysis from umbilical cord blood
Intervention Type
OTHER
ECG
Intervention Type
OTHER
Measurement of oxygen saturation
Intervention Type
OTHER
Interventions
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Echocardiography
Intervention Type
OTHER
Blood analysis from umbilical cord blood
Intervention Type
OTHER
ECG
Intervention Type
OTHER
Measurement of oxygen saturation
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Born at one of three hospitals in the Copenhagen area
Exclusion Criteria
* Failure of providing consent (parents)
Minimum Eligible Age
0 Weeks
Maximum Eligible Age
2 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Copenhagen University Hospital at Herlev
OTHER
Sponsor Role
collaborator
Copenhagen University Hospital, Hvidovre
OTHER
Sponsor Role
collaborator
Henning Bundgaard
OTHER
Sponsor Role
lead
Responsible Party
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Henning Bundgaard
Professor
Responsibility Role
SPONSOR_INVESTIGATOR
References
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Sillesen AS, Jorgensen FS, Petersen OB, Zingenberg H, Dannesbo S, Raja AA, Vogg ROB, Vejlstrup N, Iversen K, Bundgaard H. Difference in pre- and postnatal prevalence of congenital cardiac tumors in a large population-based cohort. Acta Obstet Gynecol Scand. 2025 Oct;104(10):1875-1882. doi: 10.1111/aogs.70018. Epub 2025 Aug 5.
Reference Type
DERIVED
Blixenkrone-Moller E, Dannesbo S, Dehn AM, Pihl CA, Sillesen AS, Vogg ROB, Raja AA, Colan S, Mertens L, Vejlstrup N, Bundgaard H, Iversen K. Interatrial Communications: Prevalence and Subtypes in 12,385 Newborns-a Copenhagen Baby Heart Study. Pediatr Cardiol. 2025 Aug;46(6):1570-1580. doi: 10.1007/s00246-024-03571-0. Epub 2024 Jul 13.
Reference Type
DERIVED
Molin J, Hartmann J, Paerregaard MM, Thygesen CB, Sillesen AS, Raja AA, Vogg ROB, Iversen KK, Bundgaard H, Christensen AH. The Neonatal QRS Complex and Its Association with Left Ventricular Mass. Pediatr Cardiol. 2024 Feb;45(2):248-256. doi: 10.1007/s00246-023-03361-0. Epub 2023 Dec 27.
Reference Type
DERIVED
Norregaard MMO, Basit S, Sillesen AS, Raja AA, Jorgensen FS, Iversen KK, Bundgaard H, Boyd HA, Vogg ROB. Impact of maternal age and body mass index on the structure and function of the heart in newborns: a Copenhagen Baby Heart Study. BMC Med. 2023 Dec 18;21(1):499. doi: 10.1186/s12916-023-03207-9.
Reference Type
DERIVED
Dehn AM, Paerregaard MM, Sellmer A, Dannesbo S, Blixenkrone-Moller E, Sillesen AS, Raja AA, Iversen KK, Bundgaard H, Christensen AH, Hjortdal V. Electrocardiographic Characteristics in 438 Neonates with Atrial Septal Defects. Pediatr Cardiol. 2024 Mar;45(3):580-587. doi: 10.1007/s00246-023-03324-5. Epub 2023 Nov 1.
Reference Type
DERIVED
Paerregaard MM, Hartmann J, Sillesen AS, Pihl C, Dannesbo S, Kock TO, Pietersen A, Raja AA, Iversen KK, Bundgaard H, Christensen AH. The Wolff-Parkinson-White pattern in neonates: results from a large population-based cohort study. Europace. 2023 Jul 4;25(7):euad165. doi: 10.1093/europace/euad165.
Reference Type
DERIVED
Dehn AM, Dannesbo S, Sellmer A, Hoffner L, Blixenkrone-Moller E, Sillesen AS, Raja AA, Vejlstrup N, Iversen K, Bundgaard H, Hjortdal V. Atrial Septal Defect: Larger Right Ventricular Dimensions and Atrial Volumes as Early as in the First Month After Birth-a Case-Control Study Including 716 Neonates. Pediatr Cardiol. 2023 Oct;44(7):1578-1586. doi: 10.1007/s00246-023-03211-z. Epub 2023 Jun 27.
Reference Type
DERIVED
Paerregaard MM, Hartmann J, Vogg O, Pietersen A, Boyd HA, Raja AA, Iversen KK, Bundgaard H, Christensen AH. The Impact of Maternal Age on the Neonatal Electrocardiogram. Neonatology. 2022;119(5):629-637. doi: 10.1159/000524439. Epub 2022 Jul 20.
Reference Type
DERIVED
Borresen MF, Blixenkrone-Moller E, Kock TO, Sillesen AS, Vogg ROB, Pihl CA, Norsk JB, Vejlstrup NG, Christensen AH, Iversen KK, Bundgaard H, Axelsson Raja A. Prevalence of Left Ventricular Noncompaction in Newborns. Circ Cardiovasc Imaging. 2022 Jun;15(6):e014159. doi: 10.1161/CIRCIMAGING.121.014159. Epub 2022 Jun 21.
Reference Type
DERIVED
Hartmann J, Paerregaard MM, Norsk J, Pietersen A, Iversen KK, Bundgaard H, Christensen AH. Gestational Age and Neonatal Electrocardiograms. Pediatrics. 2021 Dec 1;148(6):e2021050942. doi: 10.1542/peds.2021-050942.
Reference Type
DERIVED
Paerregaard MM, Kock J, Pihl C, Pietersen A, Iversen KK, Bundgaard H, Christensen AH. The Evolution of the Neonatal QRS Axis during the First Four Weeks of Life. Neonatology. 2021;118(2):155-162. doi: 10.1159/000513526. Epub 2021 Mar 10.
Reference Type
DERIVED
Sillesen AS, Pihl C, Raja AA, Davidsen AS, Lind LE, Dannesbo S, Navne J, Raja R, Vejlstrup N, Lange T, Bundgaard H, Iversen K. Repeatability and Reproducibility of Neonatal Echocardiography: The Copenhagen Baby Heart Study. J Am Soc Echocardiogr. 2019 Jul;32(7):895-905.e2. doi: 10.1016/j.echo.2019.02.015. Epub 2019 May 7.
Reference Type
DERIVED
Sillesen AS, Raja AA, Pihl C, Vogg ROB, Hedegaard M, Emmersen P, Sundberg K, Tabor A, Vedel C, Zingenberg H, Kruse C, Wilken-Jensen C, Nielsen TH, Jorgensen FS, Jeppesen DL, Sondergaard L, Kamstrup PR, Nordestgaard BG, Frikke-Schmidt R, Vejlstrup N, Boyd HA, Bundgaard H, Iversen K. Copenhagen Baby Heart Study: a population study of newborns with prenatal inclusion. Eur J Epidemiol. 2019 Jan;34(1):79-90. doi: 10.1007/s10654-018-0448-y. Epub 2018 Oct 10.
Reference Type
DERIVED
Other Identifiers
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H-16001518
Identifier Type: -
Identifier Source: org_study_id
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