Newborn Screening for Congenital Heart Disease (NSCHD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Fudan University
Sponsor:
Collaborators:
Songjiang Maternity&Infant Health Hospital
Songjiang District Central Hospital
Information provided by (Responsible Party):
Guoying huang, Fudan University
ClinicalTrials.gov Identifier:
NCT01665261
First received: August 9, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 3000
Study Start Date: July 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
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)"

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • declining the screening;
  • early discharge before the screening;
  • missing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665261

Contacts
Contact: Zhao Qu Ming, PHD +86 13501878567 jimmy517@126.com

Locations
China, Shanghai
Songjiang District Central Hospital Recruiting
ShangHai, Shanghai, China, 201620
Contact: Fan Z Rong, Master    +86 18918288047    47907428@qq.com   
Principal Investigator: Zhao Qu Ming, PHD         
Songjiang Maternal and Child Health Hospital Recruiting
Shanghai, Shanghai, China, 201620
Contact: Wang Ying, Master    +86 18918282208    fbywangying@hotmail.com   
Principal Investigator: Zhao Qu Ming, PHD         
Sponsors and Collaborators
Fudan University
Songjiang Maternity&Infant Health Hospital
Songjiang District Central Hospital
Investigators
Study Chair: Huang G Ying, MD PHD Children's Hospital of Fudan University
  More Information

Publications:
Responsible Party: Guoying huang, President of Children's Hospital of Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT01665261     History of Changes
Other Study ID Numbers: KY2011-366-1
Study First Received: August 9, 2012
Last Updated: August 20, 2012
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
Congenital heart disease
Newborn
Pulse oximetry
Screening

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

ClinicalTrials.gov processed this record on August 01, 2014