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Accuracy of Clinical and Diagnostic Studies for Pneumonia in Children

NCT03630380 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-09-18

No results posted yet for this study

Summary

Pneumonia continues to be a leading cause of death in children under five years of age worldwide. Many studies have evaluated clinical signs and symptoms that may predict pneumonia. A recent meta-analysis found that no singular physical exam finding predicted pneumonia. The World Health Organization (WHO) Criteria diagnose pneumonia based on fast breathing; however, tachypnea has not been shown to strongly predict pneumonia. This study will evaluate accuracy of clinical history, physical exam and WHO criteria, laboratory findings, and lung ultrasound compared with chest radiograph for the diagnosis of pneumonia in children under five years of age in a resource limited setting. Determining diagnostic accuracy of these findings may help derive a clinical decision rule that may more accurately predict which children have pneumonia than current WHO guidelines.

Conditions

Interventions

OTHER

Clinical History

We will collect clinical history for each patient (days of illness, history of fever, cough, difficulty breathing, vomiting, chest pain).

OTHER

Physical Exam Findings

We will collect physical exam findings including vital signs, WHO criteria for diagnosing pneumonia, and lung auscultation findings.

OTHER

Laboratory Findings

We will collect laboratory findings (white blood cell counts, differential, and c-reactive protein) if ordered by the clinician.

OTHER

Lung Ultrasound

We will perform lung ultrasound on all patients.

Sponsors & Collaborators

  • Patan Academy of Health Sciences

    lead OTHER

Principal Investigators

  • Darlene R House, MD · Patan Academy of Health Sciences

Eligibility

Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-05-31
Completion
2020-07-31

Countries

  • Nepal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630380 on ClinicalTrials.gov