Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
502 participants
OBSERVATIONAL
2012-10-31
2014-10-31
Brief Summary
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* 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.
Detailed Description
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Diagnostic definitions and standardised scores. The primary problem facing any study of pneumonia is accurate diagnosis. The overlap of clinical and radiological findings between severe viral infections, asthma and bacterial pneumonia can make it difficult to determine which febrile tachypneic children have wheezy diseases and which ones would benefit from antibiotic treatment. In many low-resource areas, this is further complicated by infectious diseases, such as malaria and dengue, which can have similar presentations. Early WHO tachypnea-based diagnostic protocols were intentionally over-sensitive to ensure that all children with bacterial pneumonia received antibiotics. Later attempts were made to improve the detection of wheezy diseases, by adding audible wheeze or acute bronchodilator response to the basic criteria. However, these were shown to be imprecise, particularly amongst the sickest children.
Investigators chose to formalize the diagnostic method described by Sachdev et al who classified patients into four groups (pneumonia, wheezy disease, mixed and non-respiratory) based on consultant review of a detailed history and examination plus a chest radiograph (CXR). Investigators recorded 29 items from a protocol that included history, examination, CXR and oximetry (see table). In order to combine results from data collection between centres, standardised scoring systems for conscious level and auscultation findings were used. For chest radiographs, a modification of the recently updated system recommended by the WHO was used. During the one week preparatory period, the system was explained to all involved ER physicians and pediatricians using examples and practice interpretation.
Study protocol. All children below 5 years age who present to the emergency rooms of the study hospitals with cough or difficulty breathing of less than 5 days, are identified. If their initial respiratory rate met WHO criteria for pneumonia, the study is explained by a native speaker of their primary language and they are invited to enter the study. Families are not paid to enrol but the study covers the cost of a CXR for every child plus travel expenses for outpatients to return for review on day four. After enrolment, twenty nine features of the child's history, examination and CXR are assessed by the ER physician and recorded by the study coordinator(Table 2).
After reviewing the data, the ER physician is asked to place the child into one of four diagnostic categories: pneumonia, wheezy disease (asthma and bronchiolitis), mixed (evidence of pneumonia and wheeze) and non-respiratory (malaria, dengue etc). The ER physician is solely responsible for subsequent management decisions. All study patients are reviewed four days later by a qualified pediatrician who is blinded to the ER physician's CXR interpretation and diagnosis. Based on a review of the clinical data at presentation, plus subsequent course over 4 days and a second examination, the pediatrician places the patient into one of the four diagnostic categories. This is considered the child's final diagnosis for analysis.
Statistical analysis. Logistic regression analysis will be used to determine which of the initial clinical variables had the best predictive power for pneumonia and asthma. The best cut-off values for continuous variables were established using receiver operating curve analysis. For each predictive variable, sensitivity, specificity plus positive and negative predictive value will be calculated from conventional tables using standard equations. When the predictive value of combining variables is tested, investigators will link them as 'A and/or B'. This increases sensitivity but decreases specificity, compared to using 'A and B.' Continuous variables will be displayed as mean +/- one standard deviation. Categorical variables will be displayed with box and whisker plots where the whiskers represent full range.
Table of investigations performed in the ER at presentation.
History Recorded details Cough yes/no Difficulty Breathing yes/no Lethargy yes/no Reduced feeding yes/no Fever yes/no Previous similar episodes number Vaccinations number and type
Examination Recorded details Age months Weight weight for age 'z' score Temperature ⁰ Celsius Heart rate beats/minute Respiratory rate breaths/minute Indrawing present/absent
Responsiveness score:
A fully alert V responds to voice P responds to pain U unconscious
Auscultation score:
Chest clear normal vesicular breath sounds Crackles coarse or fine inspiratory crackles/rattles Wheeze high pitched whistling noise, inspiratory or expiratory Crackles and wheeze both sounds present Bronchial breathing tracheal breath sounds heard over the lungs
Investigations Recorded details
CXR score: one or more of:
Normal ) Hyperinflation ) Minor patchy changes ) definitions, see table 3 Major patchy changes ) Lobar changes ) Pleural fluid ) Oximetry % oxygen saturation
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Tachypneic children
All tachypneic children under 5 yrs age presenting to study centres. No exclusions.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Michael Seear
Principle Investigator
Principal Investigators
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Michael D Seear, FRCPC
Role: PRINCIPAL_INVESTIGATOR
BC's Children's Hospital
Locations
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BC's Children's Hospital
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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H12-00783
Identifier Type: -
Identifier Source: org_study_id