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Clinical Trials in Denmark / NCT05838079
Recruiting Observational

Copenhagen Baby Heart Study - Impact

NCT05838079 · tracked via the Priya Life Science Denmark tracker
Sponsor
Henning Bundgaard
Phase
Observational
Started
2018-11-01
Last updated
2023-05-01

Condition(s) studied

Congenital Heart Disease

Investigational drug(s) / intervention(s)

Clinical examination

Clinical examination: Echocardiography Electrocardiography Analysis of umbilical and/or venous blood. Peripheral measurement of oxygen saturation

Study 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.

Eligibility

Sex
ALL
Min age
1 Day
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Faliure of providing concent (parents)

Primary outcome measure(s)

  • Prevalence of congenital heart disease — 10 years

Trial sites (3)

FacilityCityRegionStatus
Rigshospitalet Copenhagen University Hospital. Copenhagen Ø Denmark Recruiting
Herlev and Gentofte Hospital Herlev Denmark Recruiting
Hvidovre Hospital Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05838079 on ClinicalTrials.gov ↗ ← All trials in Denmark