Actively Recruiting

Age: 1Day - 99Years
All Genders
NCT05838079

Copenhagen Baby Heart Study - Impact

Led by Henning Bundgaard · Updated on 2023-05-01

35000

Participants Needed

3

Research Sites

556 weeks

Total Duration

On this page

Sponsors

H

Henning Bundgaard

Lead Sponsor

C

Copenhagen University Hospital at Herlev

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Copenhagen Baby Heart Study - Impact

Who Can Participate

Age: 1Day - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant in Copenhagen Baby Heart (CBH) study or
  • Family member of a CBH participant or
  • Born to mothers with pre-existing or gestational diabetes at Rigshospitalet, Hvidovre Hospital, or Herlev Hospital between July 2020 and December 2023
Not Eligible

You will not qualify if you...

  • Failure of providing consent by parents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Rigshospitalet Copenhagen University Hospital.

Copenhagen Ø, Denmark, 2100

Actively Recruiting

2

Herlev and Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

3

Hvidovre Hospital

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

H

Henning Bundgaard, MD, DMSc

CONTACT

K

Kasper Iversen, MD, DMSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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