Lung Ultrasound in Children With Severe Malaria

Completed

• Conditions: Severe Malaria
• Interventions: Device: lung ultrasound

• Registration Number: NCT04176029
• Lead Sponsor: University of Oxford

Brief 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

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2019-12-09
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children admitted with confirmed severe malaria	lung ultrasound	-

Primary Outcome Measures

Name	Time	Method
Proportion of children diagnoses	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission.	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.
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	Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.
Hospital mortality and 30 days mortality	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.
Median lung ultrasound score	On the day of hospital admission	Median lung ultrasound score (range 0 to 36) on the first lung ultrasound performed after admission.

Trial Locations

Locations (1)

The Maluku District Hospital; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the