Clinical trial NCT03187067: Pediatric Pneumonia Lung Ultrasound
Official title: Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Acute Respiratory Infection
Keywords: pneumonia
diagnostic
ultrasound
Pakistan
Mozambique
Lead sponsor: Save the Children
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Barcelona Institute for Global Health
name: Aga Khan University
First posted: 2017-06-14
Enrollment: 270
Sex: ALL
Minimum age (years): 2
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: LUS findings at enrollment
timeFrame: 8 hours
Secondary outcomes:
measure: Repeat LUS findings
timeFrame: 30 days
Other outcomes:
Locations:
city: Manhiça
country: Mozambique
facility: Centro de Investigação em Saúde de Manhiça (CISM)
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
References:
citation: 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.
citation: Lenahan 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.