The Maluku District Hospital
Kinshasa, Democratic Republic of the Congo
NCT Number: NCT04176029
A prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo.
The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).
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Notify Me1 year–14 year
All sexes
Observational
Kinshasa, Democratic Republic of the Congo
A prospective cohort study, with 171 children (between 1 - 14 years) admitted for severe malaria that will be included in the cohort. The study will take place at the Maluku District Hospital, located in Kinshasa, Democratic Republic of Congo.
Lung ultrasound will be performed on admission, h24, and unscheduled timepoints (in case of respiratory deterioration during hospital stay). Lung auscultation and peripheral capillary oxygen saturation (SpO2) will be assessed at each time points. All children will be observed from admission to hospital discharge. At 30 days a phone call will be made by the study staff to follow up clinical conditions of the child.
The total duration for each subject's participation in the study is approximately 1 month. The study period is approximately 12 months
Funder: The Wellcome Trust (ITPA grant) WT-iTP-2019/005
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical features of severe malaria
Laboratory features and other findings
Exclusion criteria
Lung ultrasound is performed using an 12-regions technique i.e. six areas on each side of the chest, two ventral, two lateral and two posterior. The lung ultrasound examination is estimated to take around 10 minutes of time.
Time frame: On the day of hospital admission
Proportion of children diagnosed with (1) respiratory distress with normal lungs (acidosis) in the first 6 hours after hospital admission, (2) concomitant pneumonia, (3) hydrostatic pulmonary oedema, (4) pleural effusion and (5) acute respiratory distress syndrome (ARDS).
Time frame: From admission to discharge, aproximately 1 week
Proportion of children without respiratory symptoms and a normal lung on lung ultrasound on admission that fulfil the criteria for a new pulmonary diagnosis >6h from admission.
Time frame: On the day of hospital admission
Median lung ultrasound score (range 0 to 36) on the first lung ultrasound performed after admission.
Time frame: From hospital admission to discharge, aproximately 1 week
Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.
Time frame: On hospital discharge, maximum 30 days after admission to hospital
Mortality rate in children with severe malaria suffering from a pulmonary complication at admission or during hospitalization and 30 day follow up.
University of Oxford
Other
Point of Care Lung Ultrasound to Differentiate Causes of Respiratory Distress in Children With Severe Malaria
Acronym: LUSiSM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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