Lung Ultrasound in Children With Severe Malaria (LUSiSM)

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

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).

Study Overview

• Status: Completed
• Conditions: Severe Malaria
• Intervention / Treatment: Device: lung ultrasound

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

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • The Maluku District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children admitted for severe malaria

Description

Inclusion Criteria:

• Children aged between 1 and 14 years;
• Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below).
• Informed consent signed

Clinical features of severe malaria

• Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children
• Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate > upper normal limit for age)
• Jaundice (visible jaundice)
• Circulatory collapse or shock: age <12 systolic blood pressure < 70mm Hg; age > 12 systolic blood pressure <80mm Hg with cool extremities or capillary refill time >3 seconds
• Spontaneous bleeding
• Multiple generalized convulsions: more than two episodes within 24h
• Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance

Laboratory features and other findings

• Metabolic acidosis (venous plasma bicarbonate < 15mmol/l or base excess < -2.2mEq/L)
• Severe anaemia (age <12: hematocrit < 15% or haemoglobin < 5g/dl; age>12: hematocrit < 20% or hemoglobin < 7 g /dl)
• Hypoglycaemia (< 2.2mmol/l or < 40mg/dl)
• Hyperparasitaemia defined as > 10%
• Hyperlactataemia (venous lactate < 5 mmol/L)
• Kidney dysfunction (blood urea >20mmol/L)

Exclusion Criteria:

• Co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. E.g. immediate transfer needed.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children admitted with confirmed severe malaria	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: University of Kinshasa; Mahidol Oxford Tropical Medicine Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: lung ultrasound; severe malaria; prevalence of pulmonary diagnoses
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: MAL19008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After completion of trial activities and reporting
• IPD Sharing Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No