Pediatric Pneumonia Lung Ultrasound (PLUS)
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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 |
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Recruitment Status :
Completed
First Posted : June 14, 2017
Last Update Posted : April 8, 2019
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Sponsor:
Save the Children
Collaborators:
Bill and Melinda Gates Foundation
Barcelona Institute for Global Health
Aga Khan University
Information provided by (Responsible Party):
Save the Children
- Study Details
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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 |
| 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 |
| 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 :
- LUS findings at enrollment [ Time Frame: 8 hours ]
Secondary Outcome Measures :
- Repeat LUS findings [ Time Frame: 30 days ]
Biospecimen Retention: Samples Without DNA
Respiratory and blood samples
Information from the National Library of Medicine
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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
| 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):
| Responsible Party: | Save the Children |
| ClinicalTrials.gov Identifier: | NCT03187067 |
| 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. |
| 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 |
Keywords provided by Save the Children:
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pneumonia diagnostic ultrasound Pakistan Mozambique |
Additional relevant MeSH terms:
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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |