Newborn Screening for Congenital Heart Disease (NSCHD)
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.
Congenital Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease|
- Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs [ Time Frame: The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed. ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665261
|Songjiang District Central Hospital|
|ShangHai, Shanghai, China, 201620|
|Songjiang Maternal and Child Health Hospital|
|Shanghai, Shanghai, China, 201620|
|Study Chair:||Huang G Ying, MD PHD||Children's Hospital of Fudan University|