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NCT02753348 Clinical Trial

Copenhagen Baby Heart

Congenital Heart Disease Clinical Trial

Official title:
Copenhagen Baby Heart

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02753348
Other study ID # H-16001518
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date November 2018

Study information
Verified date October 2020
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018. Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen saturation and analyses of umbilical cord blood. The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the yield of routine echocardiography shortly after birth and to establish reference values for echocardiography in Danish neonates. Prospective follow-up of the birth cohort is planned with the purpose to assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors.

Description:

Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018. Purpose - To assess the prevalence of congenital and inherited heart disease not detected prenatally, e.g. bicuspid aortic valve. - To assess the diagnostic and clinical yield of routine echocardiography in neonates. - To establish reference values for echocardiography and ECG for Danish neonates. - To establish reference values for routine biochemical analyses in umbilical cord blood. - To assess the prevalence of familial hypercholesterolemia in Danish newborns. - To assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors. Methods Approximately 18.000 children are born yearly in the Copenhagen area. From 1. April 2016 - 1. April 2018 the parents of all newborns will be offered enrollment in the research project when attending a routine prenatal ultrasound. Investigators plan to enroll >30.000 newborns. After birth, blood is drawn from the umbilical chord and immediately analyzed for routine biochemical markers. Samples will also be stored for future biochemical analyses and DNA sequencing. Within the first 14 days of life the children are examined with standardized echocardiography, electrocardiogram and measurements of oxygen saturation. Information about maternal and paternal health including inherited disorders within the family as well as information about the pregnancy and birth are collected in a central database. Follow-up When indicated children will be followed clinically. For research-purposes, prospective, register-based follow-up is planned for the entire birth cohort and with clinical visits for sub-groups of the population.

Recruitment information / eligibility
Status Completed
Enrollment 25000
Est. completion date November 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Weeks
Eligibility Inclusion Criteria: - Born at one of three hospitals in the Copenhagen area Exclusion Criteria: - Failure of providing consent (parents)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Echocardiography

• Blood analysis from umbilical cord blood

• ECG

• Measurement of oxygen saturation

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Henning Bundgaard Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of congenital heart defects 2 years
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