Congenital Heart DiseaseNCT02753348
Copenhagen Baby Heart
An observational study of Congenital Heart Disease, run by Henning Bundgaard.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 weeks
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Echocardiography, Blood analysis from umbilical cord blood and ECG
- How many people
- 25,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Newborns (0-14 days old, or for preterms when >2000g) born at three different hospitals in the Copenhagen area.
Who may be able to join
- Born at one of three hospitals in the Copenhagen area
Who cannot join
- Failure of providing consent (parents)
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Echocardiography, Blood analysis from umbilical cord blood, ECG, Measurement of oxygen saturation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Blood analysis from umbilical cord bloodOther
ECGOther
Measurement of oxygen saturationOther
| Study group | Role | What they receive |
|---|---|---|
| Newborns | Newborns (within 14 days from birth) Receives: Other: Echocardiography; Other: Blood analysis from umbilical cord blood; Other: ECG; Other: Measurement of oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of congenital heart defects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bundgaard
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor-investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753348
- Sponsor's protocol ID
- H-16001518
- Status last verified
- Oct 2020
- First submitted
- 24 Apr 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41555067Norsk JB, Raja AA, Paerregaard MM, Dannesbo S, Kock TO, Vogg RO, Vejlstrup N, Iversen K, Bundgaard H, Sillesen AS. High diagnostic yield of family echocardiographic screening of children with bicuspid aortic valve. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):885-893. doi: 10.1093/ehjci/jeaf293.
PubMed 41092104Sillesen 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.
PubMed 40763039Blixenkrone-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.
PubMed 39003423Molin 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.
PubMed 38151605Norregaard 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.
PubMed 38110921Dehn 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.
PubMed 37914855Paerregaard 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.
PubMed 37465966Dehn 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.
PubMed 37369832Paerregaard 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.
PubMed 35858538Borresen 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.
PubMed 35727876Hartmann 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.
PubMed 34814190Paerregaard 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.
PubMed 33691309Sillesen 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.
PubMed 31076139Sillesen 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.
PubMed 30306423
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copenhagen Baby Heart
- ClinicalTrials.gov ID
- NCT02753348
- Acronym / sponsor ID
- H-16001518
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- Henning BundgaardUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre
- Study start
- Apr 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns | – | Other: Echocardiography, Other: Blood analysis from umbilical cord blood, Other: ECG, Other: Measurement of oxygen saturationNewborns (within 14 days from birth) |
Who may qualify
- Ages
- 0 to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns (0-14 days old, or for preterms when >2000g) born at three different hospitals in the Copenhagen area.
Key inclusion criteria (1 listed)
- Born at one of three hospitals in the Copenhagen area
Key exclusion criteria (1 listed)
- Failure of providing consent (parents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography | Other | Newborns |
| Blood analysis from umbilical cord blood | Other | Newborns |
| ECG | Other | Newborns |
| Measurement of oxygen saturation | Other | Newborns |
Primary outcome
Prevalence of congenital heart defects
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 41555067Farooqui 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.
- Derived from this study: PubMed 41092104Norsk JB, Raja AA, Paerregaard MM, Dannesbo S, Kock TO, Vogg RO, Vejlstrup N, Iversen K, Bundgaard H, Sillesen AS. High diagnostic yield of family echocardiographic screening of children with bicuspid aortic valve. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):885-893. doi: 10.1093/ehjci/jeaf293.
- Derived from this study: PubMed 40763039Sillesen 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.
- Derived from this study: PubMed 39003423Blixenkrone-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.
- Derived from this study: PubMed 38151605Molin 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.
- Derived from this study: PubMed 38110921Norregaard 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.
- Derived from this study: PubMed 37914855Dehn 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.
- Derived from this study: PubMed 37465966Paerregaard 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.
- Derived from this study: PubMed 37369832Dehn 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.
- Derived from this study: PubMed 35858538Paerregaard 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.
- Derived from this study: PubMed 35727876Borresen 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.
- Derived from this study: PubMed 34814190Hartmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Henning Bundgaard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of congenital heart defects (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753348, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.