Clinical trial NCT04176029: Lung Ultrasound in Children With Severe Malaria
Official title: Point of Care Lung Ultrasound to Differentiate Causes of Respiratory Distress in Children With Severe Malaria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Malaria
Keywords: severe malaria
lung ultrasound
prevalence of pulmonary diagnoses
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: University of Kinshasa
First posted: 2019-11-25
Enrollment: 124
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children admitted for severe malaria

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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of children diagnoses
timeFrame: On the day of hospital admission
Secondary outcomes:
measure: Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission.
timeFrame: From admission to discharge, aproximately 1 week
measure: Median lung ultrasound score
timeFrame: On the day of hospital admission
measure: Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.
timeFrame: From hospital admission to discharge, aproximately 1 week
measure: Hospital mortality and 30 days mortality
timeFrame: On hospital discharge, maximum 30 days after admission to hospital
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: The Maluku District Hospital
Study officials:
References: