Lung Ultrasound in Children With Severe Malaria

Severe Malaria Clinical Trial

— LUSiSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176029
• Other study ID #: MAL19008
• Status: Completed
• Start date: December 9, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Severe Malaria

Intervention

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	The Maluku District Hospital	Kinshasa

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Mahidol Oxford Tropical Medicine Research Unit, University of Kinshasa

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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