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Multicentre pilot study evaluation of lung ultrasound for the management of paediatric pneumonia in low-resource settings: a study protocol
  1. Jennifer L Lenahan1,
  2. Giovanni Volpicelli2,
  3. Alessandro Lamorte3,
  4. Fyezah Jehan4,
  5. Quique Bassat5,6 and
  6. Amy Sarah Ginsburg1
  1. 1 International Programs, Save the Children Federation Inc, Fairfield, Connecticut, USA
  2. 2 Emergency Medicine, San Luigi Gonzaga University Hospital, Turin, Italy
  3. 3 Emergency Medicine, Parini Hospital, Aosta, Italy
  4. 4 Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan
  5. 5 ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain
  6. 6 Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
  1. Correspondence to Jennifer L Lenahan; jlenahan{at}savechildren.org

Abstract

Introduction Pneumonia is the leading infectious cause of death among children under 5 years of age worldwide. However, pneumonia is challenging to diagnose. Lung ultrasound (LUS) is a promising diagnostic technology. Further evidence is needed to better understand the role of LUS as a tool for the diagnosis of childhood pneumonia in low-resource settings.

Methods and analysis This study aims to pilot LUS in Mozambique and Pakistan and to generate evidence regarding the use of LUS as a diagnostic tool for childhood pneumonia. Children with cough <14 days with chest indrawing (n=230) and without chest indrawing (n=40) are enrolled. World Health Organization Integrated Management of Childhood Illness assessment is performed at enrolment, along with a chest radiograph and LUS examination. Respiratory and blood specimens are collected for viral and bacterial testing and biomarker assessment. Enrolled children are followed for 14 days (in person) and 30 days (phone call) post-enrolment with LUS examinations performed on Days 2, 6 and 14. Qualitative and quantitative data are also collected to assess feasibility, usability and acceptability of LUS among healthcare providers and caregivers. The primary outcome is LUS findings at enrolment with secondary outcomes including patient outcomes, repeat LUS findings, viral and bacterial test results, and patient status after 14 and 30 days of follow-up.

Ethics and dissemination This trial was approved by the Western Institutional Review Board as well as local ethics review committees at each site. We plan to disseminate study results in peer-reviewed journals and international conferences.

Trial registration number NCT03187067.

  • pneumonia
  • paediatric lung disaese
  • respiratory infection
  • imaging/CT MRI etc

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors JLL and ASG designed the study and wrote the protocol. GV, AL, FJ and QB reviewed and provided critical input to the study design and protocol. ASG wrote the first draft of the manuscript, and JLL, GV, AL, FJ and QB provided additional input. The authors worked collaboratively and made the decision to submit the final manuscript for publication.

  • Funding This research is supported by a grant from the Bill & Melinda Gates Foundation (OPP1157370) and the Save the Children Innovation Council. Hosting of LUS and CXR interpretation data via REDCAP at The Institute of Translational Health Sciences was supported by a grant from the National Institutes of Health National Center for Advancing Translational Sciences (UL1 TR002319). The authors had full access to all the data in the study and had final responsibility for the decision to submit this manuscript for publication.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Western Institutional Review Board (Puyallup, Washington, USA), the Aga Khan University Ethics Review Committee (Karachi, Pakistan), the Comité Institucional de Bioética em Saúde do Centro de Investigação em Saúde de Manhiça (Manhiça, Mozambique), the Comité Nacional de Bioética em Saúde (Maputo, Mozambique, Ref. 246/CNBS/17) and the Comite de Ética del Hospital Clínic de Barcelona (Barcelona, Spain).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data will be made available on an open access platform after the publication of the main manuscripts. Processes will be developed to facilitate data sharing for scientific utilisation in a collaborative manner.

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