Clinical trial NCT01669057: Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease
Official title: Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Congenital heart disease
DNA variation
methylation
risk factors
supplements
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Ningbo Women & Children's Hospital
name: Changzhou Maternal and Child Care Hospital
name: Maternal and Child Health Hospital of Taian
name: Maternal and Child Health Hospital of Wuxi
name: Kunshan City Maternal and Child Health
name: The First Affiliated Hospital of Xiamen University
name: Maternal and Child Health Hospital, Jiading District
name: Minhang Maternal and Children Health Care Hospital
First posted: 2012-08-20
Enrollment: 6000
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is from two ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)" and "Health and Public Welfare Research Project Sponsored by Ministry of Health of China Screening and evaluation of congenital heart disease in children of under 3 years old in the countryside(20102006)"

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.

Eligibility criteria: case group

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

Primary outcomes:
measure: genome-wide DNA SNPs and methylations
timeFrame: delivery
measure: perinatal supplements and drug using
timeFrame: three months before pregnancy till delivery
Secondary outcomes:
measure: Life risk factors of mother
timeFrame: three months before pregnancy till delivery
measure: Life risk factors of father
timeFrame: three months before pregnancy till delivery
measure: gestational weeks
timeFrame: delivery
measure: birth weight
timeFrame: delivery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
References: