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NCT03187067 Clinical Trial

Pediatric Pneumonia Lung Ultrasound

Pneumonia Clinical Trial

— PLUS  

Official title:
Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03187067
Other study ID # PLUS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2017
Est. completion date January 8, 2019

Study information
Verified date April 2019
Source Save the Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries

Recruitment information / eligibility
Status Completed
Enrollment 270
Est. completion date January 8, 2019
Est. primary completion date January 8, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 23 Months
Eligibility Inclusion Criteria (chest indrawing cases):

- Male or female, 2 through 23 months of age

- Cough <14 days or difficulty breathing

- Visible indrawing of the chest wall, with or without fast breathing

- Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit

Inclusion Criteria (non-chest indrawing controls):

- Male or female, 2 through 23 months of age

- Cough <14 days or difficulty breathing

- Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.

Locations
Country Name City State
Mozambique Centro de Investigação em Saúde de Manhiça (CISM) Manhiça
Pakistan Aga Khan University Karachi

Sponsors (4)
Lead Sponsor Collaborator
Save the Children Aga Khan University, Barcelona Institute for Global Health, Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

Mozambique,  Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary LUS findings at enrollment 8 hours
Secondary Repeat LUS findings 30 days
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