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Diagnosing Pneumonia Under Low-resource Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01997047
First received: May 29, 2013
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

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
Pneumonia
Bronchiolitis
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improving the Diagnosis of Pediatric Pneumonia at Hospital and Village Levels: A Multi-centre Indian Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 502
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tachypneic children
All tachypneic children under 5 yrs age presenting to study centres. No exclusions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is intended to clinically relevant. All tachypneic children below 5 yrs age are eligible for enrollment. There are no exclusion criteria. Sampling will be by convenience.
Criteria

Inclusion Criteria:

  • All children below 5 exceeding WHO age-dependent tachypnea criteria.

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997047

Locations
Canada, British Columbia
BC's Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Michael D Seear, FRCPC BC's Children's Hospital
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01997047     History of Changes
Other Study ID Numbers: H12-00783
Study First Received: May 29, 2013
Last Updated: December 2, 2014

Keywords provided by University of British Columbia:
Pneumonia
bronchiolitis
asthma
children
tachypnea
developing countries
diagnostic criteria

Additional relevant MeSH terms:
Pneumonia
Bronchiolitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on March 29, 2017