Copenhagen Baby Heart Study - Impact
Key facts
- Who runs it
- Henning Bundgaard
- Where
- Denmark3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 35,000 people, planned
- Started
- 1 Nov 2018
- Expected to end
- Jul 2029
- Type of study
- Observational, 3 groups
- Treatments tested
- Clinical examination
- Record updated
- 1 May 2023
Who can take part
- Age
- 1 day to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Participant in CBH or
- Family member of a participant in CBH or
- Born to mothers with pre-existing or gestational diabetes at either Rigshospitalet, Hvidovre Hospital, or Herlev Hospital during the period July 2020 through December 2023
Who cannot take part
- Faliure of providing concent (parents)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- New-borns (CBHS-I)
New-borns, within the first 30 days of birth.
Treatment: Clinical examination
- Children (CBH and CBHS-I)
Children, 3-13 years of age. The children from the original inclusion in CBH, and those included in CBHS-I.
Treatment: Clinical examination
- Family members
Children and adults, age 1-99 years of age. Some subprojects will invite the family members of the participating child for family examinations.
Treatment: Clinical examination
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 1 May 2023