Lung Ultrasound in Children With Severe Malaria (NCT04176029) | Clinical Trial Compass
CompletedNot Applicable
Lung Ultrasound in Children With Severe Malaria
Democratic Republic of the Congo124 participantsStarted 2019-12-09
Plain-language 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).
Who can participate
Age range1 Year – 14 Years
SexALL
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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)
Exclus…