Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05838079 |
| Other study ID # |
H-19038069 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
July 2029 |
Study information
| Verified date |
April 2023 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Henning Bundgaard, MD, DMSc |
| Phone |
+4535450512 |
| Email |
henning.bundgaard[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
Purpose:
1. To assess the prevalence of congenital and inherited heart disease not detected
prenatally, and through follow-up asses the consequence of these, e.g., bicuspid aortic
valve and septal defects.
2. To assess the prevalence of structural and functional anomalies detected by
echocardiography and electrocardiography shortly after birth and, by follow-up
examination, assess the consequence of these in early childhood.
3. To establish reference values for echocardiography and ECG for Danish children.
4. To assess the association between high-risk pregnancies and complications during
pregnancy (e.g., twin/multiple pregnancy, assisted human reproduction, preeclampsia, and
gestational diabetes) and the risk for congenital heart disease in the offspring and
early childhood.
5. To assess the association between maternal chronic diseases (e.g., thyroid disorders or
pre-existing diabetes) and the risk for congenital heart disease in the offspring and
early childhood.
6. 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 lifestyle, environmental and genetic factors.
Methods The birth cohort of CBH constitute over 25.000 new-borns. At birth an umbilical cord
blood sample was taken and immediately analysed for routine biochemical markers, and samples
were also stored for possibility of future analyses and DNA sequencing.
All clinical examinations (echocardiography, electrocardiography, and measurement of oxygen
saturation) took place within the first 2nd month of life, the vast majority within the 1st
month, median age at examination was 11 days (interquartile range 7-15). In addition to this
CBH has built a unique and extended database which include information about the maternal and
paternal health, the pregnancy and birth.
As part of CBHS-I subgroups of the CBH cohort (e.g., children born to mothers with diabetes
or preeclampsia, or children with abnormal findings at baseline examinations in CBH) will be
invited for follow-up examinations (echocardiography and electrocardiography). There will
also be a new inclusion of new-borns from the same geographical area and Hospitals as in CBH
in order to expand some of the sub cohorts, e.g., children born to mothers with diabetes.
