Copenhagen Baby Heart Study - Impact
CBHS-I
1 other identifier
observational
35,000
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
May 1, 2023
April 1, 2023
10.7 years
April 20, 2023
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of congenital heart disease
10 years
Study Arms (3)
New-borns (CBHS-I)
New-borns, within the first 30 days of birth.
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.
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.
Interventions
Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation
Eligibility Criteria
Participants from CBH and in some cases their family members. New-borns of mothers with pre-existing or gestational diabetes, included during CBHS-I.
You may qualify if:
- 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.
You may not qualify if:
- Faliure of providing concent (parents)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henning Bundgaardlead
- Copenhagen University Hospital at Herlevcollaborator
- Copenhagen University Hospital, Hvidovrecollaborator
Study Sites (3)
Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, 2100, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Biospecimen
Venous and/or umbilical cord blood sample for DNA extraction and analysis of biomarkers
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Bundgaard, MD, DMSc
Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark
- PRINCIPAL INVESTIGATOR
Kasper Iversen, MD, DMSc
Department of Cardiology, Herlev Hospital, Denmark.
Central Study Contacts
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 20, 2023
First Posted
May 1, 2023
Study Start
November 1, 2018
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
May 1, 2023
Record last verified: 2023-04