PneumoniaPLUSNCT03187067
Pediatric Pneumonia Lung Ultrasound
An observational study of Pneumonia and Acute Respiratory Infection, run by Save the Children at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 2 to 23 months
- Conditions the study is for
- Pneumonia, Acute Respiratory Infection
- What is being tested?
- Lung ultrasound
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Jul 2017to 8 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 23 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
- Conditions
- Pneumonia, Acute Respiratory Infection
- Being tested
- Lung ultrasound
- Keywords
- pneumonia, diagnostic, ultrasound, Pakistan, Mozambique
- Medical subject headings
- Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDevice
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| Mozambique, cases | Not described Receives: Device: Lung ultrasound | |
| Mozambique, controls | Not described Receives: Device: Lung ultrasound | |
| Pakistan, cases | Not described Receives: Device: Lung ultrasound | |
| Pakistan, controls | Not described Receives: Device: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS findings at enrollment
Measured: 8 hours
Secondary outcomes (1)
Repeat LUS findings
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start31 Jul 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Save the Children
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Barcelona Institute for Global Health, Aga Khan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187067
- Sponsor's protocol ID
- PLUS
- Acronym
- PLUS
- Status last verified
- Apr 2019
- First submitted
- 12 Jun 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Riaz A, Cambaco O, Ellington LE, Lenahan JL, Munguambe K, Mehmood U, Lamorte A, Qaisar S, Baloch B, Kanth N, Nisar MI, Volpicelli G, Bassat Q, Jehan F, Ginsburg AS. Feasibility, usability and acceptability of paediatric lung ultrasound among healthcare providers and caregivers for the diagnosis of childhood pneumonia in resource-constrained settings: a qualitative study. BMJ Open. 2021 Mar 11;11(3):e042547. doi: 10.1136/bmjopen-2020-042547.
PubMed 33707268Lenahan JL, Volpicelli G, Lamorte A, Jehan F, Bassat Q, Ginsburg AS. Multicentre pilot study evaluation of lung ultrasound for the management of paediatric pneumonia in low-resource settings: a study protocol. BMJ Open Respir Res. 2018 Dec 19;5(1):e000340. doi: 10.1136/bmjresp-2018-000340. eCollection 2018.
PubMed 30622716
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings
- ClinicalTrials.gov ID
- NCT03187067
- Acronym / sponsor ID
- PLUS / PLUS
- Conditions
- Pneumonia, Acute Respiratory Infection
- Keywords
- pneumonia, diagnostic, ultrasound, Pakistan, Mozambique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Save the ChildrenUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Barcelona Institute for Global Health, Aga Khan University
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mozambique, cases | – | Device: Lung ultrasound |
| Mozambique, controls | – | Device: Lung ultrasound |
| Pakistan, cases | – | Device: Lung ultrasound |
| Pakistan, controls | – | Device: Lung ultrasound |
Who may qualify
- Ages
- 2 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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
- Male or female, 2 through 23 months of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundLung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia. | Device | Mozambique, cases, Mozambique, controls, Pakistan, cases, Pakistan, controls |
Primary outcome
LUS findings at enrollment
Time frame: 8 hours
1 secondary outcome
Repeat LUS findings
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 33707268Riaz A, Cambaco O, Ellington LE, Lenahan JL, Munguambe K, Mehmood U, Lamorte A, Qaisar S, Baloch B, Kanth N, Nisar MI, Volpicelli G, Bassat Q, Jehan F, Ginsburg AS. Feasibility, usability and acceptability of paediatric lung ultrasound among healthcare providers and caregivers for the diagnosis of childhood pneumonia in resource-constrained settings: a qualitative study. BMJ Open. 2021 Mar 11;11(3):e042547. doi: 10.1136/bmjopen-2020-042547.
- Derived from this study: PubMed 30622716Lenahan JL, Volpicelli G, Lamorte A, Jehan F, Bassat Q, Ginsburg AS. Multicentre pilot study evaluation of lung ultrasound for the management of paediatric pneumonia in low-resource settings: a study protocol. BMJ Open Respir Res. 2018 Dec 19;5(1):e000340. doi: 10.1136/bmjresp-2018-000340. eCollection 2018.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Acute Respiratory Infection, run by Save the Children at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mozambique, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUS findings at enrollment (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187067, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.