Newborn Screening for Congenital Heart Disease

Study Overview
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Brief Summary
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The purpose of this study is to test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. The investigator's hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable accuracy.

Detailed Description
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Congenital heart defects (CHD) are among the most common major congenital anomalies, and they occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are mild or moderate. They either do not need treatment or treatment is needed only after infancy. Other defects are severe and require early treatment in infancy, which are the primary objectives of screening, because they are at risk of adverse or irreversible outcomes as a consequence of congenital heart defects. However, about half the neonates in the nursery have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary to develop a screening strategy for neonatologist and pediatrician, especially physicians in community. Screening strategy in our study consists of 7 indicators: Family history of CHD, tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The newborn babies with any of these 7 indicators positive will be considered positive-screened and echocardiography will performed. The whole study (screening for CHDs with 7 indicators and performing the echocardiography for diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital of Fudan University). The new generation Pulse Oximetry has been proved to have low intraobserver and interobserver variability, but the interobserver variability in clinical evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also assess the interobserver variability by comparing Quming Zhao and other two pediatricians (from the participating Hospital)(blind to each other).

Official Title
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Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease

Conditions
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Congenital Heart Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all consecutive live newborn infants between 6-72hours of age Exclusion Criteria: declining the screening; early discharge before the screening; missing

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs | Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography. | The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital heart disease, Newborn, Pulse oximetry, Screening