Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 6000
- Locations
- 1
- Primary Endpoint
- genome-wide DNA SNPs and methylations
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The objective of this study is to investigate the effect of parental peri-natal environmental risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our hypothesis is that the distributions of some environmental and genetic risk factors significantly differ between neonates with and without CHD.
Detailed Description
Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or great vessels. Many types of heart defects exist, most of which either obstruct blood flow in the heart or vessels near it, or cause blood to flow through the heart in an abnormal pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far people recognize that the causes of CHD are the conjunct effect of environment and genetic factors, both of which remain unclear. The current stud aims at investigating all the possible perinatal parental environmental risk factors and underlying genetic factors to CHD, including DNA variation and methylations. A hospital-based 1:1 matched case control study is conducted. Subjects were recruited through neonatal screening program, which includes a clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least one clinical indicator. The blood sample of participant will be collected and the parents of subjects will be interviewed to completed a questionnaire including general information and possible risk factors to CHD.
Investigators
Guoying huang
Professor,President
Children's Hospital of Fudan University
Eligibility Criteria
Inclusion Criteria
- •Han ethnic
- •0\~3 years old
- •screened by 7 indicator, diagnosed by ultrasound
Exclusion Criteria
- •with other brith defects
- •with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)
- •Control group
- •Inclusion Criteria:
- •Han ethnic
- •0\~3 years old
- •without any of 7 screen indicator , without CHD heart palpitations and other complaints about heart disease, born in the same hospital with cases
- •Exclusion Criteria:
- •With other birth defects
Outcomes
Primary Outcomes
genome-wide DNA SNPs and methylations
Time Frame: delivery
DNA sample from neonate blood
perinatal supplements and drug using
Time Frame: three months before pregnancy till delivery
questionnaire including supplements and drug using for mother
Secondary Outcomes
- birth weight(delivery)
- gestational weeks(delivery)
- Life risk factors of mother(three months before pregnancy till delivery)
- Life risk factors of father(three months before pregnancy till delivery)