Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838079
Status:
RECRUITING
Last Update Posted:
2023-05-01
First Post:
2023-04-20
Brief Title:
Copenhagen Baby Heart Study - Impact
Sponsor:
Henning Bundgaard
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Copenhagen Baby Heart Study - Impact
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBHS-I
Brief Summary:
Copenhagen Baby Heart Study - Impact CBHS-I is an extension to Copenhagen Baby Heart CBH which included over 25000 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
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
Detailed Description:
Copenhagen Baby Heart Study - Impact CBHS-I is an extension to Copenhagen Baby Heart CBH which included over 25000 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 eg 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 eg twinmultiple 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 eg 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 25000 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 eg 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 eg children born to mothers with diabetes
Purpose
1 To assess the prevalence of congenital and inherited heart disease not detected prenatally and through follow-up asses the consequence of these eg 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 eg twinmultiple 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 eg 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 25000 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 eg 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 eg children born to mothers with diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None