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| Name | Class |
|---|---|
| Mahidol Oxford Tropical Medicine Research Unit | OTHER |
| University of Kinshasa | OTHER |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children admitted with confirmed severe malaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lung ultrasound | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children diagnoses | 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). | On the day of hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission. | 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. | From admission to discharge, aproximately 1 week |
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Inclusion Criteria:
Clinical features of severe malaria
Laboratory features and other findings
Exclusion Criteria:
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Children admitted for severe malaria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Maluku District Hospital | Kinshasa | Democratic Republic of the Congo |
Data collected for this study will be under the custodianship of MORU. 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.
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After completion of trial activities and reporting
MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Median lung ultrasound score |
Median lung ultrasound score (range 0 to 36) on the first lung ultrasound performed after admission. |
| On the day of hospital admission |
| Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema. | Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema. | From hospital admission to discharge, aproximately 1 week |
| Hospital mortality and 30 days mortality | Mortality rate in children with severe malaria suffering from a pulmonary complication at admission or during hospitalization and 30 day follow up. | On hospital discharge, maximum 30 days after admission to hospital |
| D000079426 |
| Vector Borne Diseases |