Pediatric Pneumonia Lung Ultrasound (PLUS)

April 5, 2019 updated by: Save the Children

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mozambique
      • Manhiça, Mozambique
        • Centro de Investigação em Saúde de Manhiça (CISM)
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases will be children 2 through 23 months of age who present to a study hospital with history of cough or difficulty breathing and chest indrawing. Controls will be children 2 through 23 months of age who present with cough or difficulty breathing, but without chest indrawing, fast breathing or fever.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mozambique, cases
Device: Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Mozambique, controls
Device: Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Pakistan, cases
Device: Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Pakistan, controls
Device: Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LUS findings at enrollment
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Repeat LUS findings
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Save the Children

Collaborators

Bill and Melinda Gates Foundation
Aga Khan University
Barcelona Institute for Global Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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