Lung Ultrasound in Children With Severe Malaria

NCT ID: NCT04176029

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2021-10-30

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

Conditions

Severe Malaria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children admitted with confirmed severe malaria

lung ultrasound

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role: collaborator

University of Kinshasa

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Maluku District Hospital

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

MAL19008

Identifier Type: -

Identifier Source: org_study_id