Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease (SCPRFGBCHD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01669057
Recruitment Status :
First Posted : August 20, 2012
Last Update Posted : March 11, 2015
Children's Hospital of Fudan University
Ningbo Women & Children's Hospital
Changzhou Maternal and Child Care Hospital
Maternal and Child Health Hospital of Taian
Maternal and Child Health Hospital of Wuxi
Kunshan City Maternal and Child Health
The First Affiliated Hospital of Xiamen University
Maternal and Child Health Hospital, Jiading District
Minhang Maternal and Children Health Care Hospital
Information provided by (Responsible Party):
Guoying huang, Children's Hospital of Fudan University
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.
Condition or disease
Congenital Heart Disease
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
up to 3 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)"
0~3 years old
screened by 7 indicator, diagnosed by ultrasound
with other brith defects
with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)
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