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Pediatric Pneumonia Lung Ultrasound (PLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03187067
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Barcelona Institute for Global Health
Aga Khan University
Information provided by (Responsible Party):
Save the Children

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

Condition or disease Intervention/treatment
Pneumonia Acute Respiratory Infection Device: Lung ultrasound

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Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Ultrasound

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.




Primary Outcome Measures :
  1. LUS findings at enrollment [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Repeat LUS findings [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Respiratory and blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187067


Locations
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Mozambique
Centro de Investigação em Saúde de Manhiça (CISM)
Manhiça, Mozambique
Pakistan
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
Save the Children
Bill and Melinda Gates Foundation
Barcelona Institute for Global Health
Aga Khan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Save the Children
ClinicalTrials.gov Identifier: NCT03187067     History of Changes
Other Study ID Numbers: PLUS
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Save the Children:
pneumonia
diagnostic
ultrasound
Pakistan
Mozambique

Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Infection