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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. Identifier: NCT01665261
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Guoying huang, Fudan University

Brief Summary:
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.

Condition or disease
Congenital Heart Disease

Detailed Description:

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).

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Study Type : Observational
Actual Enrollment : 6730 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive neonates including pre-mature neonates and symptomatic neonates) will be recruited prospectively from two collaboration hospitals of the ongoing projects— "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)"

Inclusion Criteria:

  • all consecutive live newborn infants
  • between 6-72hours of age

Exclusion Criteria:

  • declining the screening;
  • early discharge before the screening;
  • missing

Information from the National Library of Medicine

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 identifier (NCT number): NCT01665261

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China, Shanghai
Songjiang District Central Hospital
ShangHai, Shanghai, China, 201620
Songjiang Maternal and Child Health Hospital
Shanghai, Shanghai, China, 201620
Sponsors and Collaborators
Children's Hospital of Fudan University
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Study Chair: Huang G Ying, MD PHD Children's Hospital of Fudan University


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Responsible Party: Guoying huang, President of Children's Hospital of Fudan University, Fudan University Identifier: NCT01665261     History of Changes
Other Study ID Numbers: KY2011-366-1
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Guoying huang, Fudan University:
Congenital heart disease
Pulse oximetry

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities