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

NCT03929133 | Unknown

• 1 other identifier: XH-16-040
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

fetal heart sounds; big data; cloud computing; congenital heart disease; data base; Acoustic structure design

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value

  The ratio of truly congenital heart disease cases divide by the total positive cases detected by the screening test.

  2days

Interventions

automatic screening machine on congenital heart disease DEVICE

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Neonatal ward patients
• Patients with echocardiography reports

You may not qualify if:

• Severe pneumonia

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Zhao Pengjun

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

Related Publications (11)

• van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.

  PMID: 22078432 BACKGROUND

• Ho TC, Ouyang H, Lu Y, Young AH, Chintala K, Detrano RC. Postprocedural outcomes of rural children undergoing correction of congenital heart lesions in Yunnan Province, China. Pediatr Cardiol. 2011 Aug;32(6):811-4. doi: 10.1007/s00246-011-9991-y. Epub 2011 Apr 11.

  PMID: 21479905 BACKGROUND

• Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Jia B, Huang GY; Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54. doi: 10.1016/S0140-6736(14)60198-7. Epub 2014 Apr 22.

  PMID: 24768155 BACKGROUND

• G. Douglas et al., Macleod's Clinical Examination. New York, NY, USA: Elsevier Health Sciences, 2009

  BACKGROUND

• A. G. Tilkian and M. B. Conover, Understanding Heart Sounds and Murmurs: With an Introduction to Lung Sounds.NewYork,NY, USA: ElsevierHealth Sciences, 2001.

  BACKGROUND

• KUN-HIS TSAI. METHOD, SYSTEM AND DEVICE FOR AUSCULTATION：US，US2016/0143612 A1[P]. 2016

  BACKGROUND

• Barry Poplaw. PORTABLE SMART STETHOSCOPE FORMED OF SMART MOBILE DEVICE AND CASING ASSEMBLY：US，US 2015/0327812 A1[P]. 2015

  BACKGROUND

• Winther S, Schmidt SE, Holm NR, Toft E, Struijk JJ, Botker HE, Bottcher M. Diagnosing coronary artery disease by sound analysis from coronary stenosis induced turbulent blood flow: diagnostic performance in patients with stable angina pectoris. Int J Cardiovasc Imaging. 2016 Feb;32(2):235-245. doi: 10.1007/s10554-015-0753-4. Epub 2015 Sep 3.

  PMID: 26335368 BACKGROUND

• Visagie C, Scheffer C, Lubbe WW, Doubell AF. Autonomous detection of heart sound abnormalities using an auscultation jacket. Australas Phys Eng Sci Med. 2009 Dec;32(4):240-50. doi: 10.1007/BF03179245.

  PMID: 20169844 BACKGROUND

• Huang GY. Screening markers of congenital heart disease and their clinical values. Chinese Journal of Practical Pediatrics , 2013(7):503-504

  BACKGROUND

• Zhang HX,Cheng XF.Heart sound analysis virtual instrument based on LabVIEW platform. Computer Technology and Development,2010,11:217-220

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Zhao Pengjun, MD

  Pediatric cardiovascular department, Shanghai xinhua hospital

  STUDY DIRECTOR

Central Study Contacts

Zhao Pengjun, MD

CONTACT

13918109566; pjunzhao@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: April 26, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 26, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)