NCT04176029

Lung Ultrasound in Children With Severe Malaria

Point of Care Lung Ultrasound to Differentiate Causes of Respiratory Distress in Children With Severe Malaria

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Severe Malaria

Interventions

Type	Name	Description
DEVICE	lung ultrasound	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.

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-10-01
• Completion: 2021-10-30
• First posted: 2019-11-25
• Last updated: 2022-06-22

Locations

1 site across 1 country: Democratic Republic of the Congo