Copenhagen Baby Heart | NCT02753348

Studies
Copenhagen Baby Heart

NCT02753348

Sponsor

Henning Bundgaard

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

25,000Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Echocardiography
Blood analysis from umbilical cord blood
ECG
Measurement of oxygen saturation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Oct 2018Actual

Completion Date

Nov 2018Actual

First Submitted Date

Apr 24, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2020

Last Update Posted Date

Oct 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henning Bundgaard, Professor, Rigshospitalet, DenmarkSponsor-Investigator

Lead Sponsor

Henning BundgaardOTHER

Collaborators

Name	Class
Copenhagen University Hospital at Herlev	OTHER
Copenhagen University Hospital, Hvidovre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Newborns		Newborns (within 14 days from birth)	Other: Echocardiography Other: Blood analysis from umbilical cord blood Other: ECG Other: Measurement of oxygen saturation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echocardiography	Other		Newborns
Blood analysis from umbilical cord blood

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of congenital heart defects		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born at one of three hospitals in the Copenhagen area

Exclusion Criteria:

Failure of providing consent (parents)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Weeks

Maximum Age

2 Weeks

Standard Ages

Child

Study Population

Newborns (0-14 days old, or for preterms when >2000g) born at three different hospitals in the Copenhagen area.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41555067	Derived	Farooqui AF, Norsk JB, Raja AA, Hjortdal V, Bjerrekaer JK, Fagerlund MR, Vogg RO, Pihl C, Bundgaard H, Iversen K, Sillesen AS. Prevalence of Congenital Aortic Valve Regurgitation in a Newborn Cohort. Pediatr Cardiol. 2026 Jan 20. doi: 10.1007/s00246-025-04149-0. Online ahead of print.
41092104	Derived	Norsk JB, Raja AA, Paerregaard MM, Dannesbo S, Kock TO, Vogg RO, Vejlstrup N, Iversen K, Bundgaard H, Sillesen AS. High diagnostic yield of family echocardiographic screening of children with bicuspid aortic valve. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):885-893. doi: 10.1093/ehjci/jeaf293.

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities