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Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data

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ClinicalTrials.gov Identifier: NCT03929133
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
This study intends to establish an automatic system for screening on children with congenital heart disease, the system include the auscultation of cardiac murmur and the test of oxygen saturation, the data was analyzed based on the cloud computing.

Condition or disease Intervention/treatment
Heart Diseases Device: automatic screening machine on congenital heart disease

Detailed Description:
This study intends to establish a system for screening of children with congenital heart disease,with the combination of cardiac auscultation , the test of oxygen saturation, the use of cloud computing and data base. The investigators decide to do this project from three main points.1:How to establish a data-base system? 2:How to get heart sound signal? 3.How to analyze so many signals?

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Positive Predictive Value [ Time Frame: 2days ]
    The ratio of truly congenital heart disease cases divide by the total positive cases detected by the screening test.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This study include between between newborn to 10 years old.Heart sound signal need to be collected to analyze children's heart health status and creat a special model of each kind of CHD.
Criteria

Inclusion Criteria:

  • Neonatal ward patients
  • Patients with echocardiography reports

Exclusion Criteria:

  • Severe pneumonia

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 ClinicalTrials.gov identifier (NCT number): NCT03929133


Contacts
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Contact: Zhao Pengjun, MD 13918109566 ext 02125078485 pjunzhao@sina.com

Locations
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China, Shanghai
Zhao Pengjun Recruiting
Shanghai, Shanghai, China, 200082
Contact: Zhao Pengjun, MD    13918109566    pjunzhao@sina.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Director: Zhao Pengjun, MD Pediatric cardiovascular department, Shanghai xinhua hospital

Publications:
G. Douglas et al., Macleod's Clinical Examination. New York, NY, USA: Elsevier Health Sciences, 2009
A. G. Tilkian and M. B. Conover, Understanding Heart Sounds and Murmurs: With an Introduction to Lung Sounds.NewYork,NY, USA: ElsevierHealth Sciences, 2001.
KUN-HIS TSAI. METHOD, SYSTEM AND DEVICE FOR AUSCULTATION:US,US2016/0143612 A1[P]. 2016
Barry Poplaw. PORTABLE SMART STETHOSCOPE FORMED OF SMART MOBILE DEVICE AND CASING ASSEMBLY:US,US 2015/0327812 A1[P]. 2015
Huang GY. Screening markers of congenital heart disease and their clinical values. Chinese Journal of Practical Pediatrics , 2013(7):503-504
Zhang HX,Cheng XF.Heart sound analysis virtual instrument based on LabVIEW platform. Computer Technology and Development,2010,11:217-220

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03929133     History of Changes
Other Study ID Numbers: XH-16-040
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigator do not plan to share the data until the project is totally completed

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
fetal heart sounds
big data
cloud computing
congenital heart disease
data base
Acoustic structure design

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