Diagnosing Pneumonia Under Low-resource Conditions
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|ClinicalTrials.gov Identifier: NCT01997047|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : September 21, 2017
Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are:
- To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions.
- To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses.
- The ultimate objective is to improve the management and outcome of acute respiratory conditions in children.
- Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.
|Condition or disease|
|Pneumonia Bronchiolitis Asthma|
|Study Type :||Observational|
|Actual Enrollment :||502 participants|
|Official Title:||Improving the Diagnosis of Pediatric Pneumonia at Hospital and Village Levels: A Multi-centre Indian Study|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||October 2014|
All tachypneic children under 5 yrs age presenting to study centres. No exclusions.
- Child's diagnosis in one of four categories (pneumonia, wheezy disease, mixed and non-respiratory) [ Time Frame: One year ]All children enrolled in the study, fulfill WHO criteria for pneumonia on day one. After assessing 29 different variables at presentation (day 1), including CXR, oximetry, pulse, respiratory rate, a qualified pediatrician makes the primary study diagnosis on day 4. Based on the results and review of progress, the consultant places the child into one of four diagnostic groups - pneumonia, wheezy disease, mixed and non-respiratory. These are the principal reference diagnoses for the rest of the analyses.
- Child's clinical outcome in three categories (better, worse, dead) [ Time Frame: One year ]After diagnostic review on day 4, the child's clinical outcome is also noted. The child is placed into three outcome categories - better, worse, dead.
- Child's oxygen saturation measured by cell-phone oximeter and bedside Massimo commercial oximeter [ Time Frame: one year ]The anesthetic department has developed a smart phone application that allows saturation readings to be made with an attachable finger probe. These readings will be compared to a those measured using a standard commercial oximeter.
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): NCT01997047
|Canada, British Columbia|
|BC's Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Michael D Seear, FRCPC||BC's Children's Hospital|