Improving Paediatric Pneumonia Diagnosis Using Digital Auscultation
![]() |
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: NCT03959956 |
Recruitment Status :
Recruiting
First Posted : May 22, 2019
Last Update Posted : December 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Childhood Pneumonia | Diagnostic Test: Recording lung sound by a Smartscope |

Study Type : | Observational |
Estimated Enrollment : | 1003 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Community Use of Digital Auscultation to Improve Diagnosis of Pediatric Pneumonia in Sylhet, Bangladesh |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | September 30, 2021 |
- Diagnostic Test: Recording lung sound by a Smartscope
Lung sound will be recorded from four chest points by an electronic stethoscope called Smartscope which can also classify the recorded lung sound.
- Quality of lung sound recording by healthcare worker [ Time Frame: At the time of enrollment ]Quality lung sound recordings using pre-determined quality metrics i.e., at least 75% interpretable lung sound segments per patient (3 out of 4 chest positions). and high between listener agreement for the presence or absence of abnormal lung sounds (kappa>0.8).
- Performance of the automated analysis of lung sound [ Time Frame: within 3 months after collection of recorded lung sound ]It will be evaluated comparing with listener interpretation of classification of lung sound; assuming agreement will be high (kappa>0.6)

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 59 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age less than 60 months
- History or observation of cough or difficult breathing
- Provide written informed consent
Exclusion Criteria:
- If enrolled within the last 30 days in this study
- Severely ill children who need to be referred immediately
- Refusal to join the study

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): NCT03959956
Contact: Salahuddin Ahmed, MBBS | +880255035439 ext 102 | S.Ahmed-18@sms.ed.ac.uk | |
Contact: Ashraful Islam, MBBS | ashraf.asmd@gmail.com |
Bangladesh | |
Zakiganj Upazila Health Complex | Recruiting |
Sylhet, Bangladesh | |
Contact: Arifa Islam, MBBS +8801715777887 taniaarifa@gmail.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT03959956 |
Other Study ID Numbers: |
PR-19004 |
First Posted: | May 22, 2019 Key Record Dates |
Last Update Posted: | December 1, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Digital auscultation Pneumonia Lung sounds IMCI LMIC |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |