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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 22, 2016
First Posted Date April 26, 2019
Last Update Posted Date April 26, 2019
Study Start Date January 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
Official Title Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
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.
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?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Heart Diseases
Intervention Device: automatic screening machine on congenital heart disease
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Neonatal ward patients
  • Patients with echocardiography reports

Exclusion Criteria:

  • Severe pneumonia
Sex/Gender
Sexes Eligible for Study: All
Ages up to 10 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Zhao Pengjun, MD 13918109566 ext 02125078485 pjunzhao@sina.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03929133
Other Study ID Numbers XH-16-040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Zhao Pengjun, MD Pediatric cardiovascular department, Shanghai xinhua hospital
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date December 2018