Clinical examination
OtherEchocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation
NCT Number: NCT05838079
Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018.
Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy.
The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.
Interested in participating?
Request Info1 day–99 year
All sexes
Observational
Rigshospitalet Copenhagen University Hospital., Copenhagen Ø, Denmark
Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018.
Purpose:
Methods The birth cohort of CBH constitute over 25.000 new-borns. At birth an umbilical cord blood sample was taken and immediately analysed for routine biochemical markers, and samples were also stored for possibility of future analyses and DNA sequencing.
All clinical examinations (echocardiography, electrocardiography, and measurement of oxygen saturation) took place within the first 2nd month of life, the vast majority within the 1st month, median age at examination was 11 days (interquartile range 7-15). In addition to this CBH has built a unique and extended database which include information about the maternal and paternal health, the pregnancy and birth.
As part of CBHS-I subgroups of the CBH cohort (e.g., children born to mothers with diabetes or preeclampsia, or children with abnormal findings at baseline examinations in CBH) will be invited for follow-up examinations (echocardiography and electrocardiography). There will also be a new inclusion of new-borns from the same geographical area and Hospitals as in CBH in order to expand some of the sub cohorts, e.g., children born to mothers with diabetes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation
Time frame: 10 years
Contact information is provided by the study sponsor or research team.
Henning Bundgaard, MD, DMSc
CONTACT
Kasper Iversen, MD, DMSc
CONTACT
Henning Bundgaard
Other
Acronym: CBHS-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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