Newborn Screening for Congenital Heart Disease (NSCHD)
|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: NCT01665261|
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : March 11, 2015
|Condition or disease|
|Congenital Heart Disease|
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).
|Study Type :||Observational|
|Actual Enrollment :||6730 participants|
|Official Title:||Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease|
|Study Start Date :||July 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||February 2013|
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|