An observational study in Respiratory Disease and Children, Only, sponsored by University of Oxford. Completed at 3 sites in 3 countries. Open to participants aged 3 Months to 14 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by University of Oxford · Observational
Study team will perform a prospective, observational study in two sites in the Democratic Republic of Congo (DRC) and Bangladesh in children aged 3 months to 14 years, admitted to hospital with acute respiratory symptoms. The Kinshasa lung ultrasound (K-LUS) approach integrates existing WHO clinical guidelines, lung ultrasound diagnostic accuracy evidence and paediatric ultrasound guidelines. The approach was built using a modified Delphi technique and integrates six LUS profiles, two clinical history features (timing of onset, trauma) and one clinical examination feature (fever) to suggest one among 10 clinical diagnosis. After the initial diagnosis is established by the treating physician, a research assistant will perform a LUS examination and apply the K-LUS approach. Comparison between the K-LUS derived diagnosis and the clinical diagnosis will be performed. After patient discharge a panel will also establish the most likely diagnosis according to all information available during patient stay.
This study is funded by the Wellcome Trust (ITPA grant) ref: WT-ITPA 2021/001
Acute respiratory distress represents one of the main reasons for hospital admission in low and middle income countries. Prompt and accurate diagnosis of the underlying pathological process is crucial to guide appropriate management. Lung Ultrasound (LUS) is an innovative, non-invasive, low-cost, point-of-care tool with high diagnostic accuracy for acute pulmonary diseases. It is a superior alternative to chest radiography (CXR), which is costly and seldom available in low-resource hospitals. To date, we lack a validated LUS-enhanced paediatric diagnostic approach specifically designed for low-resource settings. The primary objective is to test whether a paediatric diagnostic algorithm integrating key elements of patient history, the presence of fever and a systematic bedside LUS examination, changes the admission diagnosis. We also seek to describe the frequency of predefined suspected diagnoses observed and semiquantify pulmonary aeration in children admitted with respiratory symptoms. We will perform a prospective, two-center observational study in the Democratic Republic of Congo (DRC) and Bangladesh in children aged 3 months to 14 years, admitted to hospital with acute respiratory symptoms and signs. The 'Kinshasa lung ultrasound' diagnostic approach (K-LUS) was developed by a group of paediatric clinical and imaging experts based on existing WHO clinical guidelines, published LUS evidence-based frameworks, primary LUS literature on single pathologies and existing paediatric point of care ultrasound guidelines. After the initial diagnosis is established by the treating physician, a research assistant will perform a LUS examination and apply the K-LUS approach, to observe whether there is a change in the initial diagnosis. This is a purely observational study and no intervention will be applied, neither will the patient treatment be changed in relation to the study. The integration of LUS in the diagnostic approach of the critically ill paediatric patient has the potential of improving outcomes and appropriateness of care. It could provide earlier and low-cost diagnosis in both district and referral hospitals, with a potential expansion to peripheral healthcare facilities and integration in existing integrated management of childhood illness (IMCI) guidelines. Such an approach would also help allocate scarce resources by limiting second line radiological imaging techniques only to patients in need.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
This study's enrollment of 178 is below the median of 250 across 134 observational studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants and children aged 3 months old to 14 years old presenting with cough or difficulty in breathing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The percentage of diagnostic changes
The percentage of diagnostic changes prompted by the K-LUS approach compared with the initial clinical diagnosis given by the treating physician.
Time frame: Immediately after the procedure (K-LUS diagnosis)
Percentage agreement for 10 prespecified WHO clinical diagnoses
Percentage agreement for 10 prespecified WHO clinical diagnoses, namely (i) Asthma; (ii) Malaria; (iii) Anaemia/metabolic; (iv) Pneumothorax; (v) Congestive heart failure; (vi) Bronchiolitis; (vii) Pulmonary tuberculosis; (viii) Pneumonia; (ix) Pleural effusion (simple or empyema); (x) Haemothorax.
Time frame: Immediately after the procedure (K-LUS diagnosis)
The net reclassification index
The net reclassification index for parenchymal versus non-parencymal diagnosis prompted by the K-LUS protocol compared with the final diagnosis given by a panel after discharge.
Time frame: Immediately after the procedure (K-LUS diagnosis)
Lung ultrasound score
An ultrasound clip from each individual zone will be saved to the machine for assessment and scoring and quality control purposes. All lung regions will be scored using the LUS aeration score(11,23). * 'A-pattern' defined as horizontal repetitions of the pleural line (A-lines) and scored as '0'. * 'B-patterns' scored as '1' when more than two well-spaced B-lines are present that cover less than 50% of the pleural line, or as '2' when B-lines cover more than 50% of the pleural line. * 'Consolidation-pattern' will be defined as an anatomical image of consolidation \>1 cm in diameter and that will be scored as '3'.
Time frame: One time as early as possible after the initial clinical diagnosis (maximum 12 hours after the initial clinical diagnosis)
Plan to share: Yes — With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy (http://www.tropmedres.ac/data-sharing-policy).
Supporting information: Study protocol, Informed consent form
Access criteria: Refer to MORU data sharing policy with other researchers to use in the future. https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs
Data sharing details ↗ · www.tropmedres.ac
Ran from Jan 2025 to primary completion in May 2025, 4 months.
Of 60 non-industry observational studies under Respiration Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 4 months is below that.
Counting every sponsor, half of 75 studies reached it within 26 months; a quarter within 10 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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