- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665261
Newborn Screening for Congenital Heart Disease (NSCHD)
Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai
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ShangHai, Shanghai, China, 201620
- Songjiang District Central Hospital
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Shanghai, Shanghai, China, 201620
- Songjiang Maternal and Child Health Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all consecutive live newborn infants
- between 6-72hours of age
Exclusion Criteria:
- declining the screening;
- early discharge before the screening;
- missing
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.
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Collaborators and Investigators
Investigators
- Study Chair: Huang G Ying, MD PHD, Children's Hospital of Fudan University
Publications and helpful links
General Publications
- de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.
- Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.
- Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2011-366-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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