Clinical trial NCT02753348: Copenhagen Baby Heart
Official title: Copenhagen Baby Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital at Herlev
name: Copenhagen University Hospital, Hvidovre
First posted: 2016-04-27
Enrollment: 25000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Born at one of three hospitals in the Copenhagen area

Exclusion Criteria:

* Failure of providing consent (parents)

Primary outcomes:
measure: Prevalence of congenital heart defects
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.