Diagnosing Pneumonia Under Low-resource Conditions

NCT01997047 | Completed

• 1 other identifier: H12-00783
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Bronchiolitis; Asthma

Keywords

Pneumonia; bronchiolitis; asthma; children; tachypnea; developing countries; diagnostic criteria

Outcome Measures

Primary Outcomes (1)

• Child's diagnosis in one of four categories (pneumonia, wheezy disease, mixed and non-respiratory)

  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.

  One year

Secondary Outcomes (1)

• Child's clinical outcome in three categories (better, worse, dead)

  One year

Other Outcomes (1)

• Child's oxygen saturation measured by cell-phone oximeter and bedside Massimo commercial oximeter

  one year

Study Arms (1)

Tachypneic children

All tachypneic children under 5 yrs age presenting to study centres. No exclusions.

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC's Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pneumonia; Bronchiolitis; Asthma; Tachypnea

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael D Seear, FRCPC

  BC's Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

CA (1)