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NCT Number: NCT04176029

Lung Ultrasound 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).

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Key information

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Maluku District Hospital

Kinshasa, Democratic Republic of the Congo

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung ultrasound

Device

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.

Primary outcomes

  1. Proportion of children diagnoses

    Time frame: 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 outcomes

  1. Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission.

    Time frame: 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.

  2. Median lung ultrasound score

    Time frame: On the day of hospital admission

    Median lung ultrasound score (range 0 to 36) on the first lung ultrasound performed after admission.

  3. Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.

    Time frame: 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.

  4. Hospital mortality and 30 days mortality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit
  • University of Kinshasa

Registry information

Official study title

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

Acronym: LUSiSM

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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