Accuracy of Clinical and Diagnostic Studies for Pneumonia in Children

NCT03630380 | Unknown

• 1 other identifier: PAHS2
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

  1 day

• Specificity

  We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

  1 day

• Area under the receiver operator curve (ROC)

  We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

  1 day

Study Arms (1)

Single Arm

All children under five years of age with clinical suspicion of pneumonia (fever or respiratory complaints) who have a chest radiograph ordered will be consented. Clinical history, physical exam findings (temperature, respiratory rate, oxygen saturation, and lung auscultation findings), laboratory findings (white blood cell count, differential, and CRP) will be recorded. Lung ultrasound will be performed on all patients.

Other: Clinical History; Other: Physical Exam Findings; Other: Laboratory Findings; Other: Lung Ultrasound

Interventions

Clinical History OTHER

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

Single Arm

Physical Exam Findings OTHER

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

Single Arm

Laboratory Findings OTHER

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

Single Arm

Lung Ultrasound OTHER

We will perform lung ultrasound on all patients.

Single Arm

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Located in the Kathmandu valley, Patan Hospital is a large urban hospital with a 35-bed emergency department. The emergency department has an annual volume of approximately 48,000 patients, including approximately 8,000 pediatric visits. The admission rate is 20%.

You may qualify if:

• Patients presenting under age 5 years
• Presence of fever, respiratory complaints, or concern for pneumonia
• Receiving chest x-ray imaging

You may not qualify if:

• Children not receiving chest x-ray imaging as part of their workup for possible pneumonia
• Patients 5 years of age and older

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead

Study Sites (1)

Patan Academy of Health Sciences

Kathmandu, Nepal

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Darlene R House, MD

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darlene R House, MD

CONTACT

9810339799; drhouse@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Emergency Medicine

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 14, 2018
• Study Start: June 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

NE (1)