Copenhagen Baby Heart
1 other identifier
observational
25,000
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedOctober 19, 2020
October 1, 2020
2.5 years
April 24, 2016
October 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of congenital heart defects
2 years
Study Arms (1)
Newborns
Newborns (within 14 days from birth)
Interventions
Eligibility Criteria
Newborns (0-14 days old, or for preterms when \>2000g) born at three different hospitals in the Copenhagen area.
You may qualify if:
- Born at one of three hospitals in the Copenhagen area
You may not qualify if:
- Failure of providing consent (parents)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henning Bundgaardlead
- Copenhagen University Hospital at Herlevcollaborator
- Copenhagen University Hospital, Hvidovrecollaborator
Related Publications (14)
Farooqui AF, Norsk JB, Raja AA, Hjortdal V, Bjerrekaer JK, Fagerlund MR, Vogg RO, Pihl C, Bundgaard H, Iversen K, Sillesen AS. Prevalence of Congenital Aortic Valve Regurgitation in a Newborn Cohort. Pediatr Cardiol. 2026 Jan 20. doi: 10.1007/s00246-025-04149-0. Online ahead of print.
PMID: 41555067DERIVEDSillesen 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.
PMID: 40763039DERIVEDBlixenkrone-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.
PMID: 39003423DERIVEDMolin 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.
PMID: 38151605DERIVEDNorregaard 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.
PMID: 38110921DERIVEDDehn 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.
PMID: 37914855DERIVEDPaerregaard 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.
PMID: 37465966DERIVEDDehn 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.
PMID: 37369832DERIVEDPaerregaard 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.
PMID: 35858538DERIVEDBorresen 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.
PMID: 35727876DERIVEDHartmann 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.
PMID: 34814190DERIVEDPaerregaard 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.
PMID: 33691309DERIVEDSillesen 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.
PMID: 31076139DERIVEDSillesen 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.
PMID: 30306423DERIVED
Biospecimen
Blood sample from umbilical cord for DNA extraction and analysis of biomarkers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2016
First Posted
April 27, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2018
Study Completion
November 1, 2018
Last Updated
October 19, 2020
Record last verified: 2020-10