Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005153
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Etiologic Risk Factors of Cardiovascular Malformations
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-10
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:
None
Brief Summary:
To identify genetic and environmental risk factors for congenital cardiac disease
Detailed Description:
BACKGROUND
Congenital heart disease represents a major segment of clinically significant birth defects and is associated with high mortality and morbidity in infancy a childhood marred with physical limitations and repeated invasive procedures and an adulthood with increased risk of medical and social problems Previous research has been principally directed to clinical methods of diagnosis and treatment but the need for prediction and prenatal counseling requires further knowledge of environmental and familial risk factors Congenital heart disease is not one of the malformations monitored by the International Clearing House of Birth Defects Surveillance System Surveillance which does include congenital heart disease may lack diagnostic accuracy among the various reporting sources Accurate clinical studies lack comparative control information As a result the true epidemiologic features of cardiac defects remain obscure
DESIGN NARRATIVE
The design of the Baltimore-Washington Infant Study was that of a case-control study All infants under one year of age with confirmed diagnoses of congenital heart disease were eligible for inclusion if they were residents of the study area which encompassed 53 area hospitals in Maryland the District of Columbia and five counties in Virginia Case enrollment was done through five pediatric cardiology centers and through a periodic search of the obstetrics and neonatal and pathology logs of the participating hospitals Control selection was by random numbers and all resident births were eligible as controls except for those with congenital heart disease Mothers of cases and controls were interviewed at home for demographic information and information on maternal health maternal medication reproductive history lifestyle environmental exposures in the home occupation and agents transmitted to the mother by the father Data were collected on the characteristics drug use habits and occupations of the fathers Vital records and birth certificates were abstracted for all cases and controls Death certificates were also abstracted Variables including drugs lifestyle and home exposures and occupation were screened to identify which single factors were most importantly related to congenital heart disease
Cases in which congenital heart disease was part of a genetic complex were evaluated separately for environmental exposures Genetic data analysis focused on first degree relatives but extended family data were noted wherever available The genetic data analyses included estimation of recurrence risks in siblings for congenital heart disease with the same cardiac defect any cardiac defect in the sibling non cardiac birth defect and pregnancy loss in the family Parental phenotype was investigated for the presence of birth defects and known genetic disorders Twin births were assessed for concordance in zygosity Hypotheses of genetic and environmental teratogenic and coteratogenic interactions were tested Pathogenic mechanisms were further defined through anatomic and echocardiographic observations The family inquiry was expanded to include cousins Nutrition information was added on maternal vitamin A supplementation protein calories and other nutrients
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Congenital heart disease represents a major segment of clinically significant birth defects and is associated with high mortality and morbidity in infancy a childhood marred with physical limitations and repeated invasive procedures and an adulthood with increased risk of medical and social problems Previous research has been principally directed to clinical methods of diagnosis and treatment but the need for prediction and prenatal counseling requires further knowledge of environmental and familial risk factors Congenital heart disease is not one of the malformations monitored by the International Clearing House of Birth Defects Surveillance System Surveillance which does include congenital heart disease may lack diagnostic accuracy among the various reporting sources Accurate clinical studies lack comparative control information As a result the true epidemiologic features of cardiac defects remain obscure
DESIGN NARRATIVE
The design of the Baltimore-Washington Infant Study was that of a case-control study All infants under one year of age with confirmed diagnoses of congenital heart disease were eligible for inclusion if they were residents of the study area which encompassed 53 area hospitals in Maryland the District of Columbia and five counties in Virginia Case enrollment was done through five pediatric cardiology centers and through a periodic search of the obstetrics and neonatal and pathology logs of the participating hospitals Control selection was by random numbers and all resident births were eligible as controls except for those with congenital heart disease Mothers of cases and controls were interviewed at home for demographic information and information on maternal health maternal medication reproductive history lifestyle environmental exposures in the home occupation and agents transmitted to the mother by the father Data were collected on the characteristics drug use habits and occupations of the fathers Vital records and birth certificates were abstracted for all cases and controls Death certificates were also abstracted Variables including drugs lifestyle and home exposures and occupation were screened to identify which single factors were most importantly related to congenital heart disease
Cases in which congenital heart disease was part of a genetic complex were evaluated separately for environmental exposures Genetic data analysis focused on first degree relatives but extended family data were noted wherever available The genetic data analyses included estimation of recurrence risks in siblings for congenital heart disease with the same cardiac defect any cardiac defect in the sibling non cardiac birth defect and pregnancy loss in the family Parental phenotype was investigated for the presence of birth defects and known genetic disorders Twin births were assessed for concordance in zygosity Hypotheses of genetic and environmental teratogenic and coteratogenic interactions were tested Pathogenic mechanisms were further defined through anatomic and echocardiographic observations The family inquiry was expanded to include cousins Nutrition information was added on maternal vitamin A supplementation protein calories and other nutrients
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R37HL025629 | NIH | None | httpsreporternihgovquickSearchR37HL025629 |